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9d
Daratumumab Maintenance Therapy for Improving Survival in Patients with Light Chain Amyloidosis, EMILIA Trial (clinicaltrials.gov)
P2, N=96, Recruiting, Mayo Clinic | Trial completion date: Nov 2024 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Dec 2026
Trial completion date • Trial primary completion date
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Darzalex Faspro (daratumumab and hyaluronidase-fihj)
16d
Minimal Residual Disease Testing in Relapsed Systemic AL Amyloidosis (ASH 2024)
Background The only FDA-approved therapy for systemic light chain (AL) amyloidosis is daratumumab plus cyclophosphamide, bortezomib, and dexamethasone (i.e., Dara-CyBorD)...At the time of the MRD test, 30 (58.8%) patients were on active surveillance, 10 (19.6%) were on daratumumab and 9 (17.6%) on venetoclax...In patients with relapsed AL, MRD negativity is correlated with a better hematological response and could potentially play a role in clinical trial design. The impact of gender on MRD status remains an important area for further study.
Minimal residual disease
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clonoSEQ
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Venclexta (venetoclax) • bortezomib • cyclophosphamide • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
21d
Trial primary completion date
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pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
22d
GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
P1/2, N=252, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
Enrollment closed
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CD20 (Membrane Spanning 4-Domains A1)
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Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
23d
Rapid DFLC Response Predict CHR in AL Amyloidosis (clinicaltrials.gov)
P=N/A, N=50, Recruiting, Peking University People's Hospital | Not yet recruiting --> Recruiting
Enrollment open
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bortezomib • cyclophosphamide • Darzalex (daratumumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
25d
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: Jul 2025 --> Dec 2025
Trial completion date
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Darzalex Faspro (daratumumab and hyaluronidase-fihj)
29d
FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=9, Completed, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Completed
Trial completion • Trial completion date
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FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CD38 (CD38 Molecule)
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CD38 expression
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cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • FT538
30d
DARATALL-VHR: Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program (clinicaltrials.gov)
P2, N=31, Recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto | Not yet recruiting --> Recruiting | Trial completion date: Jan 2029 --> Oct 2029 | Initiation date: May 2024 --> Oct 2024 | Trial primary completion date: Jan 2029 --> Oct 2029
Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
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cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
30d
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (clinicaltrials.gov)
P2, N=130, Recruiting, University of Heidelberg Medical Center | N=70 --> 130 | Trial completion date: Oct 2027 --> Aug 2028 | Trial primary completion date: Oct 2026 --> Feb 2027
Enrollment change • Trial completion date • Trial primary completion date
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
1m
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of “Intermediate Fit” Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance (SWOG-Fall 2024)
R A N D O M I Z A T I O N Arm 1: Lenalidomide VRd-Lite (Bortezomib + Lenalidomide + Dexamethasone) Arm 2: Arm 3: DRd (Daratumumab and hyaluronidase-fihj + Lenalidomide + Dexamethasone) DRd (Daratumumab and hyaluronidase-fihj + Lenalidomide + Dexamethasone) Lenalidomide Daratumumab and hyaluronidase-fihj + Lenalidomide FALL 2024 SWOG MYELOMA 23 S2209/III Secondary Endpoints: To compare PFS in Arm 1 versus Arm 3. Among the nine patients on the DRD-DR arm evaluated for adverse events, there has been one treatment-related death from heart failure. Two additional patients experienced a Grade 4 adverse event as maximum grade (both hematologic).
Clinical • P3 data
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clonoSEQ
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS study (DGHO 2024)
Introduction: In the phase 3 PERSEUS study, subcutaneous (SC) DARA + VRd (D-VRd) induction/consolidation (ind/consol) and D-R maintenance (maint) increased PFS and depth of response (≥ complete response [CR] and MRD negativity [neg]) vs VRd ind/consol and R maint for TE NDMM. Higher rates of deep (10 –6 ) and sustained MRD neg with D-VRd ind/consol and D-R maint vs VRd ind/consol and R maint translated to improved PFS. These data support D-VRd and D-R maint as a new standard of care in TE NDMM and highlight the benefit of DARA SC in maint.
Clinical • Minimal residual disease
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clonoSEQ
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
Daratumumab (DARA)/bortezomib/lenalidomide/dexamethasone (D-VRd) with D-R maintenance therapy (Maint) in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of the PERSEUS study based on cytogenetic risk (DGHO 2024)
Introduction: In the phase 3 PERSEUS study, subcutaneous (SC) DARA + VRd induction/consolidation (ind/consol) and D-R maint improved progression-free survival (PFS) and rates of deep, durable responses, including minimal residual disease (MRD) negativity (neg) vs VRd ind/consol and R maint in TE NDMM, regardless of cytogenetic risk. Adding DARA SC to VRd ind/consol and R maint significantly improved PFS and sustained response rates, supporting D-VRd ind/consol and D-R maint as a new SOC for TE NDMM, regardless of cytogenetic risk status.
Clinical
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clonoSEQ
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
Trial primary completion date
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
Enrollment open
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lenalidomide • dexamethasone • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
Daratumumab in HLA Desensitization Prior to Transplantation (clinicaltrials.gov)
P2, N=6, Enrolling by invitation, Barry A. Boilson | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date
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Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
Trial completion • Combination therapy
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bortezomib • Darzalex (daratumumab) • prednisone • melphalan • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
2ms
Rapid dFLC Response Predict CHR in AL Amyloidosis (clinicaltrials.gov)
P=N/A, N=50, Not yet recruiting, Peking University People's Hospital
New trial
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bortezomib • cyclophosphamide • Darzalex (daratumumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
New P1 trial
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carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • SX-682
2ms
Trial completion • Enrollment change
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lenalidomide • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Trial completion date • Combination therapy
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bortezomib • cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Enrollment open
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Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients with Renal Failure (clinicaltrials.gov)
P1, N=30, Not yet recruiting, Augusta University | Initiation date: Jan 2024 --> Oct 2024
Trial initiation date
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bortezomib • cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
iinnovate-3: A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=15, Completed, Takeda | Active, not recruiting --> Completed | N=58 --> 15 | Trial completion date: Mar 2025 --> May 2024 | Trial primary completion date: Mar 2025 --> May 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
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Darzalex Faspro (daratumumab and hyaluronidase-fihj) • modakafusp alfa (TAK-573)
2ms
Enrollment closed
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lenalidomide • dexamethasone • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
DARATUMUMAB (DARA) + BORTEZOMIB/ LENALIDOMIDE/DEXAMETHASONE (VRD) IN TRANSPLANT-ELIGIBLE (TE) PATIENTS (PTS) WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM): ANALYSIS OF MINIMAL RESIDUAL DISEASE (MRD) IN THE PERSEUS TRIAL (SIE 2024)
In the primary analysis of the phase 3 PERSEUS study, subcutaneous DARA (DARA SC) + VRd (D-VRd) induction/consolidation (ind/consol) and D-R maintenance improved PFS and increased depth of response (≥CR and MRD neg) compared to VRd ind/consol and R maintenance for TE NDMM. During maintenance, a greater proportion of pts with MRD-pos status achieved MRD neg with D-R vs R. The higher rates of deep (10–6) and sustained MRD neg achieved with D-VRd ind/consol and D-R maintenance vs VRd ind/consol and R maintenance translated to a clinically meaningful benefit of improved PFS. These data further support D-VRd and D-R maintenance as a new SOC for TE pts with NDMM and highlight the benefit of DARA SC in maintenance.
Clinical • Minimal residual disease
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clonoSEQ
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
New P2 trial
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lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
3ms
Therapy-Related B-Lymphoblastic Leukemia Following Treatment for Multiple Myeloma With Unusual Surface Light Chain Expression (CAP 2024)
He received lenalidomide/bortezomib/dexamethasone chemotherapy, followed by autologous stem cell transplant and monthly subcutaneous daratumumab/lenalidomide/dexamethasone therapy. Also, the patient received chemotherapy for myeloma. Although it is not a WHO-recognized disease entity, previous publications suggest that it may represent a therapy-related B-ALL following myeloma treatment.
IO biomarker
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KRAS (KRAS proto-oncogene GTPase) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD22 (CD22 Molecule) • KDM6A (Lysine Demethylase 6A) • CD33 (CD33 Molecule) • CD34 (CD34 molecule) • CD79A (CD79a Molecule) • IRF4 (Interferon regulatory factor 4) • MME (Membrane Metalloendopeptidase) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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clonoSEQ
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lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
MonumenTAL-2: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
P1, N=167, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
Enrollment closed
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carfilzomib • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs)
3ms
Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P2, N=18, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
Enrollment closed
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Xpovio (selinexor) • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
4ms
IFM 2021-01: Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma (clinicaltrials.gov)
P2, N=74, Recruiting, University Hospital, Lille | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
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lenalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Tecvayli (teclistamab-cqyv)
4ms
FT576 in Subjects With Multiple Myeloma (clinicaltrials.gov)
P1, N=31, Active, not recruiting, Fate Therapeutics | Recruiting --> Active, not recruiting | N=168 --> 31
Enrollment closed • Enrollment change • Combination therapy
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cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • FT576
4ms
Enrollment open • Enrollment change
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • dexamethasone injection
4ms
A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1, N=18, Completed, Genentech, Inc. | Recruiting --> Completed | N=60 --> 18 | Trial completion date: Jul 2026 --> Jun 2024 | Trial primary completion date: Jan 2026 --> Jun 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
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Darzalex Faspro (daratumumab and hyaluronidase-fihj)
4ms
DarPAL: Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis (clinicaltrials.gov)
P2, N=40, Active, not recruiting, Fondazione IRCCS Policlinico San Matteo di Pavia | Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Jan 2025 | Trial primary completion date: Mar 2024 --> Nov 2024
Enrollment closed • Trial completion date • Trial primary completion date
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pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
5ms
Enrollment open
|
CD34 (CD34 molecule)
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bortezomib • cyclophosphamide • melphalan • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Hemady (dexamethasone tablets) • dexamethasone injection
5ms
Enrollment change
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carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
5ms
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab (clinicaltrials.gov)
P2, N=21, Recruiting, Weill Medical College of Cornell University | Trial completion date: Dec 2028 --> Dec 2029 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
5ms
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab (clinicaltrials.gov)
P2, N=40, Recruiting, Weill Medical College of Cornell University | Trial completion date: Jan 2034 --> Sep 2030 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
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dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
5ms
Trial primary completion date • CAR T-Cell Therapy
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • dexamethasone injection
5ms
Trial primary completion date • CAR T-Cell Therapy
|
lenalidomide • bortezomib • cyclophosphamide • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel)
5ms
Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov)
P2, N=59, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2026 --> Apr 2025
Enrollment closed • Trial primary completion date
|
carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
6ms
Trial completion date • Trial primary completion date
|
lenalidomide • dexamethasone • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)