Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
NCT04240054 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2026-01-28
Summary
This is a single-arm, open-label phase II study with a safety lead-in phase.
Conditions
Interventions
- DRUG
-
Bortezomib (1.5 mg/m\^2) subcutaneous on days 1, 8 and 15
- DRUG
-
Isatuximab
Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22
- DRUG
-
Cyclophosphamide (250 mg/m\^2) IV on days 1, 8 and 15
- DRUG
-
Dexamethasone 20 mg PO or IV (10 mg if \>75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Binod Dhakal, MD · Medical College of Wisconsin
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-02
- Primary Completion
- 2029-12-01
- Completion
- 2030-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.
NCT02086942 ·Status: UNKNOWN ·Phase: PHASE2
-
Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
NCT00378105 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation
NCT02513186 ·Status: COMPLETED ·Phase: PHASE1
-
Expression-linked and R-ISS-adapted Stratification for First Line Therapy in Multiple Myeloma Patients
NCT05665140 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Phase II Randomised Trial of Cyclophosphamide & Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma.
NCT02461888 ·Status: COMPLETED ·Phase: PHASE2
-
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
NCT01850524 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT05519085 ·Status: RECRUITING ·Phase: PHASE3
-
Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302)
NCT02440464 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
NCT03319667 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Use of Thalidomide, Lenalidomide, Carfilzomib, Bortezomib and Vorinostat in the Initial Treatment of Newly Diagnosed Multiple Myeloma Patients
NCT01554852 ·Status: UNKNOWN ·Phase: PHASE3
-
Ixazomib + Pomalidomide + Dexamethasone In MM
NCT04094961 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM)
NCT01114048 ·Status: UNKNOWN ·Phase: PHASE2
-
Treatment With Velcade (Bortezomib) Plus Dexamethasone (VD) or VD Plus Cyclophosphamide or VD Plus Lenalidomide in Patients With Multiple Myeloma Stabilized After 4 Cycles of VD
NCT00908232 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)
NCT01971658 ·Status: COMPLETED ·Phase: PHASE3
-
Ixazomib, Cyclophosphamide and Dexamethasone for Multiple Myeloma
NCT02412228 ·Status: COMPLETED ·Phase: PHASE2
-
Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT03763162 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
NCT02474563 ·Status: COMPLETED
-
Safety & Efficacy Study of Perifosine + Bortezomib +/- Dexamethasone for Multiple Myeloma Patients
NCT00401011 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
NCT01208662 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma
NCT02504359 ·Status: COMPLETED ·Phase: PHASE1
-
Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
NCT04835129 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
NCT00833560 ·Status: COMPLETED ·Phase: PHASE2
-
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
NCT01782963 ·Status: COMPLETED ·Phase: PHASE2
-
Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma
NCT03669445 ·Status: UNKNOWN ·Phase: PHASE2
-
Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma
NCT00581919 ·Status: COMPLETED ·Phase: PHASE2