^
2d
Trial completion
|
lenalidomide • Darzalex (daratumumab) • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2d
New P2 trial
|
bortezomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2d
FIL_DALYA: Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients. (clinicaltrials.gov)
P2, N=28, Recruiting, Fondazione Italiana Linfomi - ETS | Trial completion date: Jun 2024 --> Jan 2025 | Trial primary completion date: Jun 2024 --> Jan 2025
Trial completion date • Trial primary completion date
|
CD38 positive
|
bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3d
New P3 trial
|
lenalidomide • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
10d
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL (clinicaltrials.gov)
P2, N=20, Recruiting, Eastern Cooperative Oncology Group | Trial completion date: Oct 2024 --> Jun 2027 | Trial primary completion date: Oct 2024 --> Jun 2027
Trial completion date • Trial primary completion date • Minimal residual disease
|
cytarabine • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
10d
PRISM: DARA RVD For High Risk SMM (clinicaltrials.gov)
P2, N=61, Active, not recruiting, Omar Nadeem, MD | Recruiting --> Active, not recruiting | Trial completion date: Mar 2029 --> Dec 2030 | Trial primary completion date: Mar 2026 --> Dec 2026
Enrollment closed • Trial completion date • Trial primary completion date
|
Chr t(4;14) • Chr t(14;16)
|
clonoSEQ
|
lenalidomide • bortezomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
15d
Trial in Progress: Iberdomide and Daratumumab As Maintenance Therapy after an Autologous Stem Cell Transplant for Multiple Myeloma (the IBEX Trial) (ASH 2024)
Background and Significance : Lenalidomide (LEN) maintenance after autologous stem cell transplant (ASCT) therapy extends disease control in multiple myeloma (McCarthy PL, et al...EHA 2024 abstr 958).The IBEX trial, described herein, is a Phase II trial designed to evaluate the combination of IBER and subcutaneous DARA (IBER+DARA(SC)) as maintenance therapy in myeloma pts who remain MRD(+) following ASCT.Study Design and Methods : The primary objective is to assess the efficacy of post-ASCT IBER+DARA(SC) maintenance as reflected by capacity to induce MRD(-) responses using the commercially available ClonoSEQ assay with a 10-5 sensitivity...Subcutaneous DARA is weekly for cycles 1-2, every other week for cycles 3-6, then monthly thereafter, following the DARA schedule currently being used in the S1803 trial. Patients will be treated for up to 2 years on this study (26 cycles of therapy).This study is registered with ClinicalTrials.gov : ID NCT06107738
Clinical
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CRBN (Cereblon)
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clonoSEQ
|
lenalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • iberdomide (CC-220)
17d
Trial completion date
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
18d
Trial initiation date • Combination therapy
|
carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • SX-682
20d
A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=316, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jun 2027 --> Apr 2025 | Recruiting --> Active, not recruiting
Enrollment closed • Trial primary completion date
|
carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • forimtamig (RG6234)
25d
Minimal Residual Disease Response-adapted Deferral of Transplant in Dysproteinemia (MILESTONE) (clinicaltrials.gov)
P2, N=20, Recruiting, University of Alabama at Birmingham | Trial primary completion date: Jan 2025 --> Jan 2026
Trial primary completion date • Minimal residual disease
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
1m
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
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
clonoSEQ
|
Venclexta (venetoclax) • bortezomib • cyclophosphamide • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Trial primary completion date
|
pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
2ms
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
|
CD20 (Membrane Spanning 4-Domains A1)
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
2ms
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
|
bortezomib • cyclophosphamide • Darzalex (daratumumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
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 and hyaluronidase-fihj) • FT538
2ms
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
|
cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
2ms
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
|
clonoSEQ
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
clonoSEQ
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
clonoSEQ
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Trial primary completion date
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
Enrollment open
|
lenalidomide • dexamethasone • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
2ms
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
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
Trial completion • Combination therapy
|
bortezomib • Darzalex (daratumumab) • prednisone • melphalan • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
3ms
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
|
bortezomib • cyclophosphamide • Darzalex (daratumumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
New P1 trial
|
carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • SX-682
3ms
Trial completion • Enrollment change
|
lenalidomide • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
Trial completion date • Combination therapy
|
bortezomib • cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
Enrollment open
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
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
|
bortezomib • cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
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
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj) • modakafusp alfa (TAK-573)
3ms
Enrollment closed
|
lenalidomide • dexamethasone • pomalidomide • Elrexfio (elranatamab-bcmm) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
3ms
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
|
clonoSEQ
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
4ms
New P2 trial
|
lenalidomide • bortezomib • cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Carvykti (ciltacabtagene autoleucel) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
4ms
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
|
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)
|
clonoSEQ
|
lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
4ms
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
|
carfilzomib • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs)
4ms
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
|
Xpovio (selinexor) • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
5ms
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
|
lenalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Tecvayli (teclistamab-cqyv)
5ms
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
|
cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • FT576