Daratumumab

DARZALEX®

Overview

Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.

 

SparkCures ID 51
Developed By Janssen Research & Development LLC
Brand Name Darzalex®
Generic Name Daratumumab
Additional Names CD38 mAb, HuMax-CD38
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

View all active clinical trials around the US.

Verified
Phase 3 Clinical Trial Comparing the Safety and Effectiveness of Iberdomide, Daratumumab and Dexamethasone VS Daratumumab, Bortezomib, and Dexamethasone in P...
EXCALIBER RRMM
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Verified
Phase 3 Clinical Trial Comparing the Efficacy of an Investigational Medication Combined with Daratumumab or Daratumumab and Pomalidomide Versus Daratumumab, ...
MONUMENTAL-3
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Verified
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard ...
QUINTESSENTIAL-2
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Verified
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
MONUMENTAL-8
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Verified
Phase 2, Open-Label Study Evaluating the Use of an Investigational CAR-T Cell therapy in Participants with Multiple Myeloma
CARTITUDE-2
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Verified
Phase 1B / 2 Study of Selinexor in Combination With Other Treatments for Relapsed/Refractory and Newly Diagnosed Multiple Myeloma.
STOMP
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Verified
A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide
NUTRIVENTION-4
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Verified
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
DARATUMUMAB COMBINATION THERAPY
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Verified
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (ADVANCE)
ADVANCE
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SparkCures Verified Accurate, up-to-date information. Learn more

A Study to Compare Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) in Participants Wi...
MAJESTEC-7
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A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Ver...
IMMAGINE-3
View Trial
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a ...
TRIPLET INDUCTION + 1 OR 2-DRUG MAINTENANCE
View Trial
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE ...
EQUATE
View Trial
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duratio...
DRAMMATIC
View Trial
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering ...
DETER-SMM
View Trial
A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomi...
DREAMM-10
View Trial
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autole...
CARTITUDE-6
View Trial
MRD-Guided Sequential Therapy For Deep Response in Newly Diagnosed Multiple Myeloma - MASTER-2 Trial
MASTER-2
View Trial
Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
REACH
View Trial
Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma
SELINEXOR
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Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients...
IBER-KDD
View Trial
A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients With...
CYBORD PLUS DARATUMUMAB
View Trial
Teclistamab or Talquetamab in Combination With Daratumumab SC for High-Risk Smoldering Myeloma: A Clinical ...
REVIVE
View Trial
IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab as Post-Autologous Stem Cell Transplant Maintenance Ther...
IBEX
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Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS
DARA-MGUS
View Trial
A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Di...
DARA-SVD VS. DARA-RVD
View Trial
Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia (MILESTONE)
MILESTONE
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A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myelo...
D-CLAPD
View Trial
A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multipl...
SELINEXOR
View Trial
Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly Newly Diagnosed ...
SUBQ DARATUMUMAB IN ELDERLY PATIENTS
View Trial
An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligib...
DARATUMUMAB COMBINATION INDUCTION
View Trial
A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Au...
AMMBITION
View Trial
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Ad...
IDP-023
View Trial
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments f...
LINVOSELTAMAB
View Trial
Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven...
VENETOCLAX PLUS LENALIDOMIDE
View Trial
COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide (COMMANDER)
COMMANDER
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Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for the Treatment of Newly Diagnosed Multiple Myelom...
IDEAL
View Trial
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multip...
RADIOIMMUNOTHERAPY
View Trial
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in C...
ABBV-383
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APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple My...
APG-2575
View Trial
Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients W...
SX-682
View Trial
The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
LIGHT CHAIN CAST NEPHROPATHY IN MYELOMA PATIENTS
View Trial
Pilot Study of Daratumumab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD...
DARATUMUMAB FOR PATIENTS WITH RENAL FAILURE
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Untreated / Newly Diagnosed Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.

Verified
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
MONUMENTAL-8
View Trial
Verified
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (ADVANCE)
ADVANCE
View Trial

SparkCures Verified Accurate, up-to-date information. Learn more

A Study to Compare Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) in Participants Wi...
MAJESTEC-7
View Trial
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a ...
TRIPLET INDUCTION + 1 OR 2-DRUG MAINTENANCE
View Trial
Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE ...
EQUATE
View Trial
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duratio...
DRAMMATIC
View Trial
A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomi...
DREAMM-10
View Trial
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autole...
CARTITUDE-6
View Trial
MRD-Guided Sequential Therapy For Deep Response in Newly Diagnosed Multiple Myeloma - MASTER-2 Trial
MASTER-2
View Trial
Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
REACH
View Trial
Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma
SELINEXOR
View Trial
A Phase II Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab for Patients With...
CYBORD PLUS DARATUMUMAB
View Trial
A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Di...
DARA-SVD VS. DARA-RVD
View Trial
Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia (MILESTONE)
MILESTONE
View Trial
Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly Newly Diagnosed ...
SUBQ DARATUMUMAB IN ELDERLY PATIENTS
View Trial
An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligib...
DARATUMUMAB COMBINATION INDUCTION
View Trial
A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Au...
AMMBITION
View Trial
Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven...
VENETOCLAX PLUS LENALIDOMIDE
View Trial
Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for the Treatment of Newly Diagnosed Multiple Myelom...
IDEAL
View Trial
The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
LIGHT CHAIN CAST NEPHROPATHY IN MYELOMA PATIENTS
View Trial
Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Verified
Phase 3 Clinical Trial Comparing the Safety and Effectiveness of Iberdomide, Daratumumab and Dexamethasone VS Daratumumab, Bortezomib, and Dexamethasone in P...
EXCALIBER RRMM
View Trial
Verified
Phase 3 Clinical Trial Comparing the Efficacy of an Investigational Medication Combined with Daratumumab or Daratumumab and Pomalidomide Versus Daratumumab, ...
MONUMENTAL-3
View Trial
Verified
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard ...
QUINTESSENTIAL-2
View Trial
Verified
Phase 2, Open-Label Study Evaluating the Use of an Investigational CAR-T Cell therapy in Participants with Multiple Myeloma
CARTITUDE-2
View Trial
Verified
Phase 1B / 2 Study of Selinexor in Combination With Other Treatments for Relapsed/Refractory and Newly Diagnosed Multiple Myeloma.
STOMP
View Trial
Verified
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
DARATUMUMAB COMBINATION THERAPY
View Trial

SparkCures Verified Accurate, up-to-date information. Learn more

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Ver...
IMMAGINE-3
View Trial
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duratio...
DRAMMATIC
View Trial
Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients...
IBER-KDD
View Trial
IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab as Post-Autologous Stem Cell Transplant Maintenance Ther...
IBEX
View Trial
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myelo...
D-CLAPD
View Trial
A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multipl...
SELINEXOR
View Trial
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments f...
LINVOSELTAMAB
View Trial
Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven...
VENETOCLAX PLUS LENALIDOMIDE
View Trial
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multip...
RADIOIMMUNOTHERAPY
View Trial
APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple My...
APG-2575
View Trial
Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients W...
SX-682
View Trial
The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
LIGHT CHAIN CAST NEPHROPATHY IN MYELOMA PATIENTS
View Trial
Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Verified
Phase 3 Clinical Trial Comparing the Efficacy of an Investigational Medication Combined with Daratumumab or Daratumumab and Pomalidomide Versus Daratumumab, ...
MONUMENTAL-3
View Trial
Verified
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard ...
QUINTESSENTIAL-2
View Trial
Verified
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
MONUMENTAL-8
View Trial
Verified
Phase 2, Open-Label Study Evaluating the Use of an Investigational CAR-T Cell therapy in Participants with Multiple Myeloma
CARTITUDE-2
View Trial
Verified
Phase 1B / 2 Study of Selinexor in Combination With Other Treatments for Relapsed/Refractory and Newly Diagnosed Multiple Myeloma.
STOMP
View Trial
Verified
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
DARATUMUMAB COMBINATION THERAPY
View Trial

SparkCures Verified Accurate, up-to-date information. Learn more

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Ver...
IMMAGINE-3
View Trial
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duratio...
DRAMMATIC
View Trial
Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients...
IBER-KDD
View Trial
IBEX: Phase 2 Trial of Iberdomide + SQ Daratumumab as Post-Autologous Stem Cell Transplant Maintenance Ther...
IBEX
View Trial
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myelo...
D-CLAPD
View Trial
A Study of Selinexor, in Combination With Carfilzomib, Daratumumab or Pomalidomide in Patients With Multipl...
SELINEXOR
View Trial
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Ad...
IDP-023
View Trial
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments f...
LINVOSELTAMAB
View Trial
Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven...
VENETOCLAX PLUS LENALIDOMIDE
View Trial
Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multip...
RADIOIMMUNOTHERAPY
View Trial
APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple My...
APG-2575
View Trial
Phase 1 Trial of SX-682, a CXCR 1/2 Inhibitor, in Combination With Standard of Care Treatment in Patients W...
SX-682
View Trial
The Effect of Novel Treatments in Improving Renal Outcomes Among Patients With Light Chain Cast Nephropathy
LIGHT CHAIN CAST NEPHROPATHY IN MYELOMA PATIENTS
View Trial
Smoldering Myeloma

The following is a listing of clinical trials for patients with Smoldering Myeloma.

Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering ...
DETER-SMM
View Trial
Teclistamab or Talquetamab in Combination With Daratumumab SC for High-Risk Smoldering Myeloma: A Clinical ...
REVIVE
View Trial
Monoclonal Gammopathy of Undetermined Significance (MGUS)

The following is a listing of clinical trials for patients with Monoclonal Gammopathy of Undetermined Significance (MGUS).

Phase IIa Study to Evaluate Daratumumab for Polyneuropathy Associated With MGUS
DARA-MGUS
View Trial

Published Results

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma

December 12, 2023

The PERSEUS study, conducted in collaboration with the European Myeloma Network, found that induction and consolidation treatment with DARZALEX FASPRO® in combination with bortezomib, lenalidomide and dexamethasone (D-VRd), followed by DARZALEX FASPRO® and lenalidomide (D-R) maintenance, reduced the risk of disease progression or death by 58 percent (Hazard Ratio [HR], 0.42; 95 percent Confidence Interval [CI] 0.30-0.59; P <0.0001), compared to bortezomib, lenalidomide and dexamethasone (VRd) alone followed by lenalidomide (R) maintenance.1 The quadruplet regimen also significantly increased the depth of response compared to treatment with VRd alone, with higher rates of CR or better, stringent complete response (sCR), and MRD negativity.

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Resources

Darzalex Faspro combo benefits patients new to MM and transplant

December 19, 2023

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Efficacy and Safety of Daratumumab (DARA) Monotherapy in Patients with Intermediate-Risk or High-...

December 09, 2023

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Darzalex Combo Increases Response Rates in Newly Diagnosed Multiple Myeloma Patients, Trial Shows

September 23, 2019

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Carfilzomib and Daratumumab Combination Proves Utility in CANDOR Study for Relapsed Myeloma Patients

September 13, 2019

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Request for Darzalex as Faster and Easier Under-the-skin Infusion for Multiple Myeloma Before FDA

July 17, 2019

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Darzalex Combo Extends Survival in Newly Diagnosed Myeloma Patients, Phase 3 Trial Shows

June 21, 2019

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Genmab Announces Positive Topline Results in Phase III COLUMBA Study of Subcutaneous Daratumumab

February 25, 2019

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FDA Asked to OK Darzalex as Combo Therapy for Newly Diagnosed Group of Multiple Myeloma Patients

January 28, 2019

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FDA Approves Daratumumab/VMP Combination as First-Line Therapy in Multiple Myeloma

May 08, 2018

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Daratumumab Demonstrates Single-Agent Activity in Smoldering Myeloma

December 12, 2017

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