Darzalex

(Daratumumab)

ApprovedMonoclonal antibody

Daratumumab is used to treat multiple myeloma (a cancer of blood cells) and certain other blood cancers. It works by helping the immune system recognize and destroy cancer cells.[2] Darzalex is currently approved and in use across 48 indications[4].[1]

Darzalex is one of 645 small molecule programs targeting Immune Thrombocytopenia. It is currently in Approved.

Indications

285

Total Trials

Active Trials

644

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Immune ThrombocytopeniaActive, not recruiting

Relapsed or Refractory Multiple MyelomaWithdrawn

DexamethasoneCompleted

DaratumumabUnknown status

Autoimmune DisordersRecruiting

Kidney FailureRecruiting

NephropathyActive, not recruiting

Haematological MalignancyRecruiting

Recurrent Multiple MyelomaRecruiting

Adult Patients With Adverse Risk Acute Myeloblastic LeukemiaRecruiting

Immune ThrombocytopeniaPhase 2

Active, not recruiting

Relapsed or Refractory Multiple MyelomaPhase 3

Withdrawn

DexamethasonePhase 2

Completed

DaratumumabPhase 2

Unknown status

Autoimmune DisordersPreclinical

Recruiting

Kidney FailurePhase 2

Recruiting

NephropathyPreclinical

Active, not recruiting

Haematological MalignancyPreclinical

Recruiting

Recurrent Multiple MyelomaPreclinical

Recruiting

Adult Patients With Adverse Risk Acute Myeloblastic LeukemiaPhase 1

Recruiting

Showing 10 of 48 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Darzalex

Johnson & Johnson

Approved

2 2

Cabenuva

GSK

Preclinical

1 3

Norvir

AbbVie

Preclinical

1 4

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/ANot yet recruiting

Combination Therapy

NCT07015021

Q4 2026

Phase 1/2Active, not recruiting

MRD

NCT05434689

Phase 2Active, not recruiting

Multiple Myeloma

NCT03236428

Phase 1/2Not yet recruiting

Multiple Myeloma

NCT05581875

Phase 1Not yet recruiting

Cerebral Cavernous Malformation

NCT07026604

Phase 2Active, not recruiting

Multiple Myeloma

NCT04925193

Clinical

Trials by Indication[1]

Multiple Myeloma116 trials

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03652064·395 enrolled

Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Completed·CCorvus Pharmaceuticals, Inc.·Phase 1·NCT04280328·7 enrolled

A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

Completed· Takeda logo

Takeda·Phase 2·NCT03439293·61 enrolled

Show 113 more trials

Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma

Terminated·OOncopeptides AB·Phase 3·NCT04649060·54 enrolled

A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT03357952·10 enrolled

Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT

Unknown status·PPETHEMA Foundation··NCT05218603·100 enrolled

A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02519452·120 enrolled

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02252172·737 enrolled

A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02195479·706 enrolled

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03301220·390 enrolled

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02076009·569 enrolled

Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS

Recruiting·SStichting European Myeloma Network·Phase 2·NCT06189833·200 enrolled

A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03234972·213 enrolled

A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

Completed·JJohnson & Johnson Private Limited·Phase 4·NCT03768960·150 enrolled

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

Active, not recruiting·SStichting European Myeloma Network·Phase 3·NCT03710603·709 enrolled

China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Active, not recruiting· GSK logo

GSK·Phase 3·NCT06868654·72 enrolled

A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

Recruiting· GSK logo

GSK·Phase 3·NCT06679101·520 enrolled

Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma With Kidney Failure

Terminated·EEmory University·Phase 2·NCT04352205·17 enrolled

Daratumumab, Azacitidine, and Dexamethasone for Treatment of Patients With Recurrent or Refractory Multiple Myeloma Previously Treated With Daratumumab

Terminated·UUniversity of California, San Francisco·Phase 2·NCT04407442·5 enrolled

A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multiple Myeloma

Suspended·HHackensack Meridian Health·Phase 2·NCT04661137·96 enrolled

FT576 in Subjects With Multiple Myeloma

Completed·FFate Therapeutics·Phase 1·NCT05182073·31 enrolled

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

Recruiting·—·Phase 2·NCT05896228·30 enrolled

STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA

Active, not recruiting·UUniversity of Turin, Italy·Phase 4·NCT03829371·450 enrolled

Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma

Unknown status·HHellenic Society of Hematology·Phase 2·NCT03475628·57 enrolled

Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02874742·224 enrolled

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

Terminated· Teva logo

Teva·Phase 1·NCT05556616·15 enrolled

Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·UUniversity of Chicago·Phase 1/2·NCT01665794·25 enrolled

A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory

Not yet recruiting·HHellenic Society of Hematology·Phase 1/2·NCT05581875·48 enrolled

A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

Completed· Roche logo

Roche·Phase 1·NCT05243342·18 enrolled

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

Active, not recruiting·NNantes University Hospital·Phase 2·NCT06353022·103 enrolled

Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years

Active, not recruiting·PPETHEMA Foundation·Phase 3·NCT03742297·462 enrolled

Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)

Completed·IiOMEDICO AG··NCT05284591·96 enrolled

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

Active, not recruiting·SStichting European Myeloma Network·Phase 3·NCT05257083·759 enrolled

Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT05835726·188 enrolled

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Active, not recruiting· GSK logo

GSK·Phase 3·NCT04246047·494 enrolled

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03989414·424 enrolled

Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT03500445·75 enrolled

Phase II Study of Daratumumab Pre-Mobilization and Post-ASCT in Multiple Myeloma

Withdrawn·WWake Forest University Health Sciences·Phase 2·NCT04230031

Dose Escalation Study of JNJ-54767414 (Daratumumab) in Chinese Participants With Relapsed or Refractory Multiple Myeloma Who Failed at Least 2 Prior Lines of Systemic Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02852837·50 enrolled

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

Recruiting·EEuropean Myeloma Network B.V.·Phase 3·NCT06932562·1,000 enrolled

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

Active, not recruiting·UUniversity of Miami·Phase 2·NCT04268498·310 enrolled

Efficacy and Safety Study of Pembrolizumab (MK-3475) in Combination With Daratumumab in Participants With Relapsed Refractory Multiple Myeloma (MK-3475-668/KEYNOTE-668)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 2·NCT03221634

Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT03477539·49 enrolled

Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma

Recruiting·SSCRI Development Innovations, LLC·Phase 2·NCT06974786·100 enrolled

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT03000452·18 enrolled

A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03290950·75 enrolled

Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.

Completed· Amgen logo

Amgen·Phase 3·NCT03158688·466 enrolled

Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01946477·186 enrolled

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01985126·124 enrolled

A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02918331·7 enrolled

Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma

Withdrawn·—·Phase 2·NCT03841565

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Completed·IIntergroupe Francophone du Myelome·Phase 3·NCT02541383·1,085 enrolled

A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02951819·101 enrolled

Daratumumab in Combination With Bortezomib and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma

Unknown status·SSingapore General Hospital·Phase 2·NCT03695744·27 enrolled

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03412565·265 enrolled

Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT06140966·54 enrolled

A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Not yet recruiting· Regeneron logo

Regeneron·Phase 2/3·NCT07428369·1,570 enrolled

Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Recruiting·—·Phase 2·NCT06505369·50 enrolled

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

Terminated·AAnaveon AG·Phase 1·NCT05641324·4 enrolled

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT02773030·466 enrolled

A Study of an Accelerated Infusion Rate of Daratumumab in Patients With Relapsed and Refractory Multiple Myeloma

Completed·CCanadian Myeloma Research Group·Phase 2·NCT03697629·40 enrolled

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02316106·123 enrolled

CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma.

Active, not recruiting·CCancer Trials Ireland·Phase 1·NCT04667663·16 enrolled

Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma

Terminated·MMayo Clinic·Phase 1·NCT04892264·5 enrolled

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT03314181·156 enrolled

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Active, not recruiting·PPETHEMA Foundation·Phase 2·NCT05849610·30 enrolled

A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02116569·9 enrolled

Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma

Active, not recruiting·UUS Oncology Research·Phase 2·NCT04782687·73 enrolled

Reduce Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed Multiple Myeloma

Terminated·SSrinivas Devarakonda·Phase 2·NCT04205240·1 enrolled

Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma

Active, not recruiting·UUniversity of Colorado, Denver·Phase 2·NCT04925193·18 enrolled

Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation

Suspended·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT06348147·39 enrolled

A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03217812·220 enrolled

Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Active, not recruiting· GSK logo

GSK·Phase 3·NCT06868667·24 enrolled

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02136134·498 enrolled

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT05308654·34 enrolled

A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02807454·37 enrolled

Daratumumab in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma and Severe Renal Impairment

Completed·UUniversitätsklinikum Hamburg-Eppendorf·Phase 2·NCT02977494·22 enrolled

Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT06409702·59 enrolled

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01998971·240 enrolled

NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

Completed·NNektar Therapeutics·Phase 1·NCT04136756·30 enrolled

A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04121260·21 enrolled

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Recruiting·UUniversity Hospital, Lille·Phase 2·NCT05572229·74 enrolled

Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma

Recruiting·—·Phase 1·NCT05363111·15 enrolled

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma

Recruiting·GGenrix (Shanghai) Biopharmaceutical Co., Ltd.·Phase 3·NCT07452198·358 enrolled

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06232707

A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma

Terminated·HHackensack Meridian Health·Phase 2·NCT04700176·1 enrolled

Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive

Unknown status·AAzienda Ospedaliera Universitaria Senese·Phase 2·NCT03992170·50 enrolled

Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Not yet recruiting·EEuropean Myeloma Network B.V.·Phase 2·NCT07107529·150 enrolled

Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma

Terminated· Gilead logo

Gilead·Phase 2·NCT04892446·36 enrolled

"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "

Completed·VVejle Hospital·Phase 2/3·NCT02419118·4 enrolled

Study of Daratumumab in Combination With Dexamethasone in Resistant or Refractory Multiple Myeloma

Completed·UUniversity Hospital, Lille·Phase 2·NCT02626481·64 enrolled

An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients

Active, not recruiting·NNantes University Hospital·Phase 2·NCT03606577·50 enrolled

Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma

Terminated· AbbVie logo

AbbVie·Phase 1·NCT04895410·8 enrolled

Daratumumab, Ixazomib, & Dexamethasone or Daratumumab, Bortezomib, & Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Active, not recruiting·EEmory University·Phase 2·NCT03942224·49 enrolled

Study of Bromodomain and Extra-Terminal Protein (BET) Inhibitor RO6870810 as Mono- and Combination Therapy in Advanced Multiple Myeloma

Completed· Roche logo

Roche·Phase 1·NCT03068351·24 enrolled

Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03763162·40 enrolled

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST)

Recruiting·PPETHEMA Foundation·Phase 2·NCT07045909·30 enrolled

Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma

Unknown status·UUniversity Hospital, Toulouse·Phase 2·NCT03669445·45 enrolled

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT03012880·80 enrolled

Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT02477891

SELIBORDARA: Selinexor, Bortezomib and Daratumumab in Multiple Myeloma

Active, not recruiting·PPETHEMA Foundation·Phase 2·NCT03589222·62 enrolled

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT01592370·320 enrolled

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Completed· Roche logo

Roche·Phase 1/2·NCT06055075·19 enrolled

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Recruiting· AbbVie logo

AbbVie·Phase 2/3·NCT07095452·660 enrolled

A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible

Unknown status·HHellenic Society of Hematology·Phase 1/2·NCT05280275·36 enrolled

Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03622775·13 enrolled

Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT03701321

Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma

Active, not recruiting·—·Phase 2·NCT03236428·42 enrolled

A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM)

Completed· Roche logo

Roche·Phase 1·NCT02431208·85 enrolled

Daratumumab in Treating Patients With Multiple Myeloma

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT02944565·28 enrolled

Short Course Daratumumab in Patients With Multiple Myeloma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03490344·10 enrolled

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

Terminated· Teva logo

Teva·Phase 1/2·NCT05590377·15 enrolled

Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study

Active, not recruiting·MMayo Clinic·Phase 1/2·NCT05392946·49 enrolled

Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial

Active, not recruiting·MMayo Clinic·Phase 2·NCT05497804·17 enrolled

Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial

Withdrawn·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04024384

Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease

Active, not recruiting·SStichting European Myeloma Network·Phase 2·NCT04166565·41 enrolled

Dexamethasone5 trials

Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA)

Unknown status·NNational University of Ireland, Galway, Ireland·Phase 1·NCT02955810·18 enrolled

Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH

Terminated·FFondazione Italiana Linfomi - ETS·Phase 2·NCT04251065·8 enrolled

Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM

Recruiting·—·Phase 2·NCT04176718·43 enrolled

Show 2 more trials

Carfilzomib in Combination With Daratumumab, Lenalidomide and Dexamethasone in Transplant-ineligible NDMM Patients

Completed·TTel-Aviv Sourasky Medical Center·Phase 2·NCT04065789·41 enrolled

Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM

Active, not recruiting·LLarysa Sanchez·Phase 2·NCT04052880·17 enrolled

Daratumumab5 trials

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03320707·66 enrolled

The DART Study- Daratumumab Treatment in ITP

Unknown status·OOstfold Hospital Trust·Phase 2·NCT04703621·21 enrolled

Daratumumab in Treatment of PGNMID and C3 GN

Completed·FFernando Fervenza·Phase 2·NCT03095118·12 enrolled

Show 2 more trials

Biomarkers of AKI in Patients Receiving Daratumumab

Completed·—··NCT06549634·20 enrolled

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM

Terminated·OOncopeptides AB·Phase 1/2·NCT03481556·56 enrolled

Amyloidosis4 trials

Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial

Recruiting·MMayo Clinic·Phase 2·NCT05898646·96 enrolled

A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis

Completed·SStichting European Myeloma Network·Phase 2·NCT04131309·40 enrolled

Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE)

Withdrawn·—·Phase 1/2·NCT05486481

Show 1 more trial

Daratumumab Combined With Bortezomib and Dexamethasone in Mayo 04 Stage III Light Chain Amyloidosis

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04474938·40 enrolled

Immune Thrombocytopenia4 trials

Anti-CD38 Antibody Treating Elderly Patients With Primary Immune Thrombocytopenia (ITP)

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07063199·30 enrolled

Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06838962·30 enrolled

A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia

Active, not recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05562882·60 enrolled

Show 1 more trial

Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07297563·160 enrolled

50 more indications

AL amyloidosis3 trials

Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis

Completed·UUniversity Hospital, Limoges·Phase 2·NCT02816476·40 enrolled

Daratumumab for the Treatment of Patients With AL Amyloidosis

Completed·—·Phase 1/2·NCT02841033·22 enrolled

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04304144·25 enrolled

Newly Diagnosed3 trials

FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT06187441·599 enrolled

Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 2·NCT04009109·79 enrolled

A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM

Unknown status·TThe First Affiliated Hospital of Soochow University·N/A·NCT05088330·76 enrolled

Chronic Lymphocytic Leukemia3 trials

Daratumumab and Ibrutinib in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia

Active, not recruiting·JJennifer Woyach·Phase 1·NCT03447808·15 enrolled

Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction

Active, not recruiting·FFrench Innovative Leukemia Organisation·Phase 2·NCT03734198·29 enrolled

Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study

Terminated·MMayo Clinic·Phase 2·NCT04230304·8 enrolled

Combination Therapy2 trials

The Efficacy and Safety of the Combination Therapy of Daratumumab, Cabozantinib, Pomalidomide, and Dexamethasone (D-KPd) in the Treatment of High-risk First-time Relapsed or Primary Refractory MM Patients

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·N/A·NCT07015021·72 enrolled

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02060188·385 enrolled

Macroglobulinemia2 trials

A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia

Completed·—·Phase 2·NCT03187262·13 enrolled

Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

Terminated·WWeill Medical College of Cornell University·Phase 2·NCT03679624·1 enrolled

Myelodysplastic Syndrome2 trials

Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03067571·7 enrolled

A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·SSyros Pharmaceuticals·Phase 2·NCT02807558·155 enrolled

Breast Cancer2 trials

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Terminated·MMayo Clinic·Phase 1·NCT03432741·17 enrolled

A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03098550·105 enrolled

Acute Lymphoblastic Leukemia2 trials

Use of a New Medicine "Daratumumab" to Treat Left-over Cancer in a Blood Cancer Called "T Acute Lymphoblastic Leukemia"

Recruiting·TTata Memorial Centre·Phase 2·NCT07021677·18 enrolled

Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT03207542

Plasma Cell Leukemia2 trials

Daratumumab, Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin Hydrochloride, and Lenalidomide in Treating Participants With Plasma Cell Leukemia

Withdrawn·—·Phase 1·NCT03591744

Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05054478·29 enrolled

Aplastic Anemia2 trials

The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT07287228·37 enrolled

Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1·NCT05832216·10 enrolled

Prostate Cancer2 trials

Neoadjuvant Listeria or Daratumumab in Prostate Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT03035357

Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03177460·33 enrolled

Lymphoma2 trials

A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02927925·32 enrolled

A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma

Recruiting·AAIDS Malignancy Consortium·Phase 1·NCT04139304·15 enrolled

Systemic Lupus Erythematosus1 trial

An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus

Unknown status·—·Phase 2·NCT04810754·10 enrolled

Intravenous1 trial

Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT04264884

Acute Myeloid Leukemia1 trial

Daratumumab and Donor Lymphocyte Infusion in Treating Participants With Relapsed Acute Myeloid Leukemia After Stem Cell Transplant

Terminated·SSumithira Vasu·Phase 1/2·NCT03537599·4 enrolled

Glioblastoma1 trial

Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma

Active, not recruiting·WWest Virginia University·Phase 1/2·NCT04922723·16 enrolled

Cerebral Cavernous Malformation1 trial

Daratumumab for Familial Cerebral Cavernous Malformations: A Single-Arm Safety and Efficacy Study

Not yet recruiting·—·Phase 1·NCT07026604·10 enrolled

TED1 trial

Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex

Completed·SStichting European Myeloma Network·Phase 3·NCT03180736·304 enrolled

Maintenance Therapy1 trial

Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (ElMMA)

Not yet recruiting·NNantes University Hospital·Phase 2·NCT06931704·176 enrolled

Virus-associated Tumors1 trial

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT02488759·578 enrolled

Risk Stratification1 trial

Risk Stratification and MRD-driven Maintenance for MM After ASCT

Recruiting·PPeking University People's Hospital·N/A·NCT06697483·100 enrolled

T-cell acute lymphoblastic leukemia1 trial

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03384654·47 enrolled

Advanced Hematologic Malignancies1 trial

FT538 in Subjects With Advanced Hematologic Malignancies

Terminated·FFate Therapeutics·Phase 1·NCT04614636·42 enrolled

Sickle Cell Disease1 trial

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell Antibody

Recruiting·—·Phase 2·NCT06358638·12 enrolled

Non-Small Cell Lung Cancer1 trial

A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT03023423·100 enrolled

POEMS syndrome1 trial

Treatment of POEMS Syndrome With Daratumumab

Completed·UUniversity of Arkansas·Phase 2·NCT04396496·2 enrolled

Kidney Transplant1 trial

DARA-MVI Study (Daratumumab for Microvascular Inflammation in Kidney Transplantation)

Active, not recruiting·UUniversity Hospital, Martin·Phase 4·NCT07274462·20 enrolled

Plasma Cell Disorders1 trial

Subcutaneous Daratumumab Administration in the Thigh Vs Abdomen in Plasma Cell Disorders

Recruiting·UUniversity of Maryland, Baltimore·Phase 1/2·NCT07075510·30 enrolled

Toxic Epidermal Necrolysis1 trial

New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.

Not yet recruiting·HHospices Civils de Lyon·Phase 1/2·NCT07110662·9 enrolled

Chemotherapy1 trial

Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06570915·20 enrolled

Mild to Moderate Alzheimer's Disease1 trial

Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease

Completed·—·Phase 2·NCT04070378·16 enrolled

Antibody-mediated Rejection1 trial

Daratumumab for Late Antibody-Mediated Rejection

Recruiting·UUniversity Hospital, Martin·N/A·NCT07081126·20 enrolled

Blood Cancer1 trial

A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.

Withdrawn·EEpizyme, Inc.·Phase 1/2·NCT05205252

Efficacy and Safety1 trial

An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L

Recruiting·HHellenic Society of Hematology·Phase 2·NCT06636552·43 enrolled

Induction Therapy1 trial

Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy

Withdrawn·AAttaya Suvannasankha·Phase 2·NCT04223661

Heart Transplantation1 trial

Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation

Withdrawn·RRonald Witteles·Phase 1·NCT04088903

ESS1 trial

Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

Active, not recruiting·IInternational Myeloma Foundation·Phase 2·NCT03289299·87 enrolled

Refractory1 trial

A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)

Recruiting·NNanjing IASO Biotechnology Co., Ltd.·Phase 3·NCT06464991·240 enrolled

Diffuse Large B-Cell Lymphoma1 trial

An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02413489·36 enrolled

Hematologic Cancer1 trial

IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Recruiting·IIndapta Therapeutics, INC.·Phase 1/2·NCT06119685·128 enrolled

Neuromyelitis Optica1 trial

Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders

Active, not recruiting·TTianjin Medical University General Hospital·Phase 2/3·NCT05403138·135 enrolled

Hematopoietic Cell Transplantation1 trial

A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03556332·41 enrolled

Bladder Cancer1 trial

Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03473730·17 enrolled

Myelodysplastic Syndromes1 trial

Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT03011034·34 enrolled

Nephrotic Syndrome1 trial

Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome

Unknown status·IIstituto Giannina Gaslini·Phase 2·NCT05704400·20 enrolled

Newly Diagnosed Patients1 trial

Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

Not yet recruiting·PPETHEMA Foundation·Phase 2·NCT05527340·140 enrolled

MRD1 trial

COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide

Active, not recruiting·UUniversity of Alabama at Birmingham·Phase 1/2·NCT05434689·80 enrolled

Renal Transplantation1 trial

The Safety and Efficacy of CD38 Monoclonal Antibody Monotherapy for CaAMR in Renal Transplantation

Unknown status·FFirst Affiliated Hospital of Zhejiang University·N/A·NCT05913596·15 enrolled

Relapsed or Refractory Hematologic Malignancies1 trial

GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies

Terminated· Genmab logo

Genmab·Phase 1/2·NCT04824794·130 enrolled

Unspecified2 trials

Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM

Withdrawn·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT05408026

GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Recruiting·UUniversity of Heidelberg Medical Center·Phase 2·NCT05695508·160 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 16, 2015

DARZALEX

NDA BLA761036

Nov 16, 2015

DARZALEX

BLA BLA761036

Nov 21, 2016

DARZALEX

NDA BLA761036

Nov 21, 2016

DARZALEX

NDA BLA761036

Jun 16, 2017

DARZALEX

NDA BLA761036

May 7, 2018

DARZALEX

NDA BLA761036

Jun 18, 2018

DARZALEX

NDA BLA761036

Feb 8, 2019

DARZALEX

NDA BLA761036

Jun 27, 2019

DARZALEX

NDA BLA761036

Jul 16, 2019

DARZALEX

NDA BLA761036

Sep 26, 2019

DARZALEX

NDA BLA761036

Apr 17, 2020

DARZALEX

NDA BLA761036

Jun 29, 2020

DARZALEX

NDA BLA761036

Aug 20, 2020

DARZALEX

NDA BLA761036

Jan 11, 2021

DARZALEX FASPRO

NDA BLA761145

Jan 15, 2021

DARZALEX FASPRO

NDA BLA761145

Feb 8, 2021

DARZALEX FASPRO

NDA BLA761145

Mar 12, 2021

DARZALEX

NDA BLA761036

Mar 12, 2021

DARZALEX FASPRO

NDA BLA761145

Jul 9, 2021

DARZALEX

NDA BLA761036

Jul 9, 2021

DARZALEX FASPRO

NDA BLA761145

Nov 30, 2021

DARZALEX FASPRO

NDA BLA761145

Jan 21, 2022

DARZALEX FASPRO

NDA BLA761145

Jan 21, 2022

DARZALEX

NDA BLA761036

Mar 4, 2022

DARZALEX

NDA BLA761036

Nov 1, 2022

DARZALEX

NDA BLA761036

Nov 2, 2022

DARZALEX FASPRO

NDA BLA761145

Jan 19, 2023

DARZALEX

NDA BLA761036

Jul 30, 2024

DARZALEX FASPRO

NDA BLA761145

Jul 31, 2024

DARZALEX

NDA BLA761036

Jan 23, 2025

DARZALEX

NDA BLA761036

Apr 10, 2025

DARZALEX

NDA BLA761036

Nov 6, 2025

DARZALEX FASPRO

NDA BLA761145

Nov 14, 2025

DARZALEX FASPRO

NDA BLA761145

Nov 19, 2025

DARZALEX FASPRO

NDA BLA761145

Jan 27, 2026

DARZALEX FASPRO

NDA BLA761145

Feb 12, 2026

DARZALEX FASPRO

NDA BLA761145

May 28, 2026

DARZALEX

NDA BLA761036

Sources

References

[1]
ClinicalTrials.gov — 285 trial records for Daratumumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Darzalex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Daratumumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Daratumumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761036). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Lymphocyte Differentiation Antigen CD38 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Darzalex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Multiple Myeloma116 trials

Dexamethasone5 trials

Daratumumab5 trials

Amyloidosis4 trials

Immune Thrombocytopenia4 trials

AL amyloidosis3 trials

Newly Diagnosed3 trials

Chronic Lymphocytic Leukemia3 trials

Combination Therapy2 trials

Macroglobulinemia2 trials

Myelodysplastic Syndrome2 trials

Breast Cancer2 trials

Acute Lymphoblastic Leukemia2 trials

Plasma Cell Leukemia2 trials

Aplastic Anemia2 trials

Prostate Cancer2 trials

Lymphoma2 trials

Systemic Lupus Erythematosus1 trial

Intravenous1 trial

Acute Myeloid Leukemia1 trial

Glioblastoma1 trial

Cerebral Cavernous Malformation1 trial

TED1 trial

Maintenance Therapy1 trial

Virus-associated Tumors1 trial

Risk Stratification1 trial

T-cell acute lymphoblastic leukemia1 trial

Advanced Hematologic Malignancies1 trial

Sickle Cell Disease1 trial

Non-Small Cell Lung Cancer1 trial

POEMS syndrome1 trial

Kidney Transplant1 trial

Plasma Cell Disorders1 trial

Toxic Epidermal Necrolysis1 trial

Chemotherapy1 trial

Mild to Moderate Alzheimer's Disease1 trial

Antibody-mediated Rejection1 trial

Blood Cancer1 trial

Efficacy and Safety1 trial

Induction Therapy1 trial

Heart Transplantation1 trial

ESS1 trial

Refractory1 trial

Diffuse Large B-Cell Lymphoma1 trial

Hematologic Cancer1 trial

Neuromyelitis Optica1 trial

Hematopoietic Cell Transplantation1 trial

Bladder Cancer1 trial

Myelodysplastic Syndromes1 trial

Nephrotic Syndrome1 trial

Newly Diagnosed Patients1 trial

MRD1 trial

Renal Transplantation1 trial

Relapsed or Refractory Hematologic Malignancies1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News