Actively Recruiting
Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
Led by Medical College of Wisconsin · Updated on 2026-01-28
41
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label phase II study with a safety lead-in phase.
CONDITIONS
Official Title
Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written consent before any study procedures
- Male or female subjects 18 years or older
- Eligible for high-dose therapy and autologous stem cell transplantation
- No prior multiple myeloma therapy except limited use of dexamethasone, bortezomib, or cyclophosphamide for up to four weeks
- Documented multiple myeloma with at least 10% monoclonal plasma cells or biopsy-proven plasmacytoma
- Evidence of organ damage or myeloma-defining events such as hypercalcemia, anemia, high bone marrow plasma cells, high light chain ratio, or renal insufficiency
- Measurable disease as defined by serum or urine M-protein levels or abnormal serum free light chains
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Females must be postmenopausal, surgically sterile, or use effective contraception during and after treatment
- Males must agree to use effective contraception or abstain during and after treatment
You will not qualify if you...
- Need for immediate treatment for renal failure such as dialysis (for renal impaired cohort)
- History or treatment of other malignancies within 3 years, except certain treated cancers without active disease
- Central nervous system involvement by multiple myeloma
- Known HIV, active hepatitis B or untreated hepatitis C infection
- Medical conditions interfering with study participation or safety, including unsuitability for stem cell transplant
- Significant cardiac disease including recent heart attack, unstable angina, heart failure, uncontrolled arrhythmia, ECG abnormalities, or uncontrolled hypertension
- Low blood counts or abnormal liver function tests at enrollment
- Allergies or intolerance to monoclonal antibodies, isatuximab, or related products
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or light-chain amyloidosis
- Inability to comply with study protocol due to medical or psychological reasons
- Pregnant or breastfeeding women or those planning pregnancy
- Men planning to father a child during and after treatment
- Major surgery within two weeks before starting study treatment or planned surgery during study participation
- Uncontrolled pulmonary disease or recent hospitalization for pulmonary issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here