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1d
Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM (clinicaltrials.gov)
P2, N=18, Recruiting, Larysa Sanchez | N=38 --> 18 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Feb 2024 --> Dec 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
lenalidomide • bortezomib • Ninlaro (ixazomib) • Darzalex Faspro (daratumumab/hyaluronidase)
2d
Trial primary completion date • Combination therapy
|
lenalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
2d
Trial completion date • Combination therapy
|
pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
16d
Trial completion
|
Darzalex (daratumumab) • Darzalex Faspro (daratumumab/hyaluronidase)
16d
CASTOR: Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P3, N=498, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Jan 2024
Trial completion • Trial completion date
|
bortezomib • Darzalex (daratumumab) • Darzalex Faspro (daratumumab/hyaluronidase)
22d
Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
P2, N=70, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Feb 2025 --> Sep 2026 | Initiation date: Feb 2024 --> Nov 2024 | Trial primary completion date: Feb 2025 --> Sep 2026
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
|
lenalidomide • bortezomib • Xpovio (selinexor) • Darzalex Faspro (daratumumab/hyaluronidase) • Hemady (dexamethasone tablets)
23d
Enrollment open • Combination therapy
|
Chr t(11;14)
|
Venclexta (venetoclax) • lenalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Hemady (dexamethasone tablets)
27d
MonumenTAL-2: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
P1, N=182, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Dec 2024 --> Jul 2025
Trial primary completion date
|
carfilzomib • pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Talvey (talquetamab-tgvs)
27d
Trial completion date • Combination therapy
|
bortezomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Tecvayli (teclistamab-cqyv) • dexamethasone injection
1m
A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens (clinicaltrials.gov)
P2, N=265, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Nov 2023 --> Feb 2024
Trial completion date
|
lenalidomide • bortezomib • carfilzomib • melphalan • Darzalex Faspro (daratumumab/hyaluronidase)
1m
Home Based Daratumumab Administration for Patients With Multiple Myeloma (clinicaltrials.gov)
P1, N=20, Active, not recruiting, Thomas Jefferson University | Trial completion date: Jan 2025 --> Nov 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
Trial completion date • Trial primary completion date
|
Darzalex Faspro (daratumumab/hyaluronidase)
1m
AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov)
P3, N=390, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2025 --> Jul 2025
Trial completion date
|
Darzalex Faspro (daratumumab/hyaluronidase)
1m
New P3 trial
|
carfilzomib • pomalidomide • Empliciti (elotuzumab) • Darzalex Faspro (daratumumab/hyaluronidase) • alnuctamab (CC-93269)
2ms
A Study of TTI-622 in Combination With Daratumumab Hyaluronidase-fihj in People With Multiple Myeloma (clinicaltrials.gov)
P1, N=7, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=32 --> 7
Enrollment closed • Enrollment change • Combination therapy
|
Darzalex Faspro (daratumumab/hyaluronidase) • maplirpacept (TTI-622)
2ms
DARA-AIHA: The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia (clinicaltrials.gov)
P1, N=2, Active, not recruiting, Dartmouth-Hitchcock Medical Center | Recruiting --> Active, not recruiting | N=10 --> 2
Enrollment closed • Enrollment change
|
LDH elevation
|
Darzalex Faspro (daratumumab/hyaluronidase)
2ms
Enrollment open
|
Chr t(11;14)
|
Venclexta (venetoclax) • Darzalex Faspro (daratumumab/hyaluronidase)
2ms
GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
P1/2, N=252, Recruiting, Genmab | Trial completion date: Feb 2029 --> Dec 2026
Trial completion date
|
CD20 (Membrane Spanning 4-Domains A1)
|
Darzalex Faspro (daratumumab/hyaluronidase) • GEN3014
3ms
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor (clinicaltrials.gov)
P4, N=50, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Initiation date: Aug 2023 --> Nov 2023
Trial initiation date
|
Darzalex Faspro (daratumumab/hyaluronidase)
3ms
FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=11, Active, not recruiting, Masonic Cancer Center, University of Minnesota | Trial primary completion date: Dec 2025 --> Jan 2024
Trial primary completion date • Combination therapy
|
FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CD38 (CD38 Molecule)
|
CD38 expression
|
cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab/hyaluronidase) • FT538
3ms
Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=46, Active, not recruiting, University of California, San Diego | Trial primary completion date: Oct 2023 --> Mar 2024
Trial primary completion date
|
Ninlaro (ixazomib) • pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase)
3ms
Trial completion date • Trial primary completion date • Combination therapy
|
Chr t(11;14)
|
Venclexta (venetoclax) • lenalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Hemady (dexamethasone tablets)
3ms
A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
P1/2, N=27, Terminated, Takeda | Phase classification: P1b/2 --> P1/2 | Active, not recruiting --> Terminated; Enrolment Challenges
Phase classification • Trial termination • Combination therapy
|
Darzalex Faspro (daratumumab/hyaluronidase) • mezagitamab (TAK-079) • subasumstat (TAK-981)
3ms
New P2 trial • Minimal residual disease
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab/hyaluronidase)
3ms
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma (clinicaltrials.gov)
P2, N=28, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
Enrollment open
|
CD4 (CD4 Molecule)
|
Darzalex Faspro (daratumumab/hyaluronidase)
3ms
Enrollment open
|
clonoSEQ
|
Darzalex Faspro (daratumumab/hyaluronidase) • iberdomide (CC-220)
3ms
Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE) (clinicaltrials.gov)
P1/2, N=46, Not yet recruiting, Alfred Chung, MD | N=78 --> 46 | Trial completion date: Aug 2027 --> Dec 2027 | Trial primary completion date: Aug 2027 --> Dec 2027
Enrollment change • Trial completion date • Trial primary completion date
|
Chr t(11;14)
|
Venclexta (venetoclax) • dexamethasone • Darzalex Faspro (daratumumab/hyaluronidase)
3ms
Enrollment closed • Combination therapy
|
Darzalex Faspro (daratumumab/hyaluronidase) • modakafusp alfa (TAK-573)
4ms
New P2 trial
|
lenalidomide • bortezomib • Xpovio (selinexor) • Darzalex Faspro (daratumumab/hyaluronidase) • Hemady (dexamethasone tablets)
4ms
Home Based Daratumumab Administration for Patients With Multiple Myeloma (clinicaltrials.gov)
P1, N=20, Active, not recruiting, Thomas Jefferson University | Recruiting --> Active, not recruiting
Enrollment closed
|
Darzalex Faspro (daratumumab/hyaluronidase)
4ms
Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma (clinicaltrials.gov)
P2, N=28, Not yet recruiting, National Cancer Institute (NCI) | N=16 --> 28
Enrollment change
|
CD4 (CD4 Molecule)
|
Darzalex Faspro (daratumumab/hyaluronidase)
4ms
Trial completion date
|
bortezomib • dexamethasone • Darzalex Faspro (daratumumab/hyaluronidase)
4ms
AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov)
P3, N=390, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Sep 2024 --> May 2024
Trial primary completion date
|
Darzalex Faspro (daratumumab/hyaluronidase)
4ms
Trial completion date • Combination therapy
|
bortezomib • Darzalex (daratumumab) • prednisone • melphalan • Darzalex Faspro (daratumumab/hyaluronidase)
4ms
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis (clinicaltrials.gov)
P2, N=150, Recruiting, Janssen Research & Development, LLC | Trial completion date: Nov 2025 --> Dec 2027
Trial completion date
|
bortezomib • cyclophosphamide • Darzalex Faspro (daratumumab/hyaluronidase) • dexamethasone injection
4ms
Trial completion date • CAR T-Cell Therapy
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab/hyaluronidase) • Carvykti (ciltacabtagene autoleucel) • dexamethasone injection
4ms
A Study of Daratumumab (clinicaltrials.gov)
P3, N=500, Recruiting, Janssen Research & Development, LLC | Phase classification: P3b --> P3
Phase classification
|
lenalidomide • Darzalex (daratumumab) • carfilzomib • pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • dexamethasone injection
4ms
MonumenTAL-2: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
P1, N=182, Recruiting, Janssen Research & Development, LLC | Phase classification: P1b --> P1
Phase classification
|
carfilzomib • pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Talvey (talquetamab-tgvs)
4ms
Phase classification • Combination therapy
|
pomalidomide • Darzalex Faspro (daratumumab/hyaluronidase) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
4ms
Phase classification • Combination therapy
|
lenalidomide • bortezomib • Libtayo (cemiplimab-rwlc) • carfilzomib • pomalidomide • Sarclisa (isatuximab-irfc) • Darzalex Faspro (daratumumab/hyaluronidase) • Ogsiveo (nirogacestat) • fianlimab (REGN3767) • linvoseltamab (REGN5458)
4ms
Enrollment open • Combination therapy
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • STK11 (Serine/threonine kinase 11)
|
KRAS mutation • KRAS G12C • BRAF mutation • HER-2 mutation • KRAS G12
|
Opdivo (nivolumab) • Darzalex Faspro (daratumumab/hyaluronidase)
4ms
Dara-MGUS: Daratumumab for Polyneuropathy Associated With MGUS (clinicaltrials.gov)
P2, N=20, Recruiting, Georgetown University | Not yet recruiting --> Recruiting | Phase classification: P2a --> P2
Enrollment open • Phase classification
|
Darzalex Faspro (daratumumab/hyaluronidase)
4ms
Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) Alone in Chinese Patients with Relapsed/Refractory Multiple Myeloma: Final Analysis of the Phase 3 Lepus Study (ASH 2023)
Introduction: Daratumumab is a human IgGκ monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. In this final analysis of LEPUS with a median follow-up of >3 years, D-Vd continued to demonstrate substantial efficacy benefits versus Vd and the safety profile of D-Vd remained stable, with no new safety concerns identified. In addition, several patients switched their daratumumab administration from IV to SC, which was preferred by most patients who switched. These results further support the feasibility of daratumumab SC administration and the use of D-Vd as a standard of care in Chinese patients with RRMM who have received ≥1 prior line of therapy.
Clinical • P3 data
|
bortezomib • Darzalex (daratumumab) • Darzalex Faspro (daratumumab/hyaluronidase)