RecruitingMultiple Myeloma
Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This is a single-arm, open-label phase II study with a safety lead-in phase.
Sponsor: Medical College of Wisconsin
You may qualify if…
- ✓ 1. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- ✓ 2. Male or female subjects ≥18 years.
- ✓ 3. Patients must be eligible for high-dose therapy and autologous stem cell transplantation as per institutional guidelines.
- ✓ 4. No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m\^2) and/or cyclophosphamide up to 500 mg/m\^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than four weeks prior to enrollment. If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment (at least one of the following: Serum protein electrophoresis (SPEP)/Immunofixation electrophoresis (IFE), 24-hour urine protein with urine protein electrophoresis (UPEP)/ IFE, serum free light chains and bone marrow procedure) must be available.
- ✓ 5. Patients must have documented multiple myeloma as defined by the criteria below (a, b, and c):
- ✓ 1. Monoclonal plasma cells in the bone marrow of ≥10% or presence of a biopsy proven plasmacytoma AND
- ✓ 2. Evidence of organ damage or myeloma-defining events (MDE) that can be attributed to the underlying proliferative plasma cell disorder (at least one of the following):
- ✓ Hypercalcemia: corrected serum calcium \>1 mg/dL higher than the upper limit of normal (ULN) or \>11 mg/Dl.
You may not qualify if…
- ✕ 1. For renal impaired Cohort A subjects, any subject who requires immediate treatment for management of renal failure (including, but not limited to, dialysis). Such treatment is allowed once the patient becomes stable, based on investigator's discretion.
- ✕ 2. Diagnosed or treated for malignancy other than multiple myeloma, except:
- ✕ Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment or documentation that the malignancy required/requires no treatment at time of enrollment.
- ✕ Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- ✕ Adequately treated carcinoma in situ (e.g., cervical, breast) with no evidence of disease.
- ✕ 3. Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
- ✕ 4. Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have untreated or active hepatitis C.
- ✕ 5. Concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study. Specifically, any potential subject who is unsuitable for ASCT would be excluded from the study.
Where it's recruiting
Wisconsin
Milwaukee
Source: ClinicalTrials.gov · NCT04240054 · last updated 2026-01-28