Actively Recruiting
A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
Led by Oncotherapeutics · Updated on 2025-01-16
39
Participants Needed
2
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14)
CONDITIONS
Official Title
A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple myeloma with either clonal bone marrow plasma cells >10% or biopsy-proven plasmacytoma
- Evidence of active myeloma with at least one of the following: end organ damage (hypercalcemia, renal insufficiency, anemia, or bone lesions), ≥60% clonal plasma cells in bone marrow, serum free light chain ratio ≥100 with involved light chain ≥100 mg/L, or more than one focal lesion ≥5mm on MRI
- Measurable multiple myeloma disease with specific monoclonal protein levels or involved serum free light chain levels
- Presence of t(11;14) chromosomal translocation confirmed by FISH or cytogenetic analysis
- Absolute neutrophil count ≥1.5 x 10^9/L
- Platelet count ≥75 x 10^9/L
- Hemoglobin ≥8.0 g/dL within 21 days prior to enrollment
- Creatinine clearance ≥30 mL/min by Cockcroft-Gault method
- Total bilirubin ≤2.0 mg/dL
- AST and ALT ≤2 times the upper limit of normal
- Serum potassium between 3.0 and 5.5 mEq/L
- Female participants of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception
- ECOG performance status ≤2
- Must have received at least one prior line of therapy including proteasome inhibitor, lenalidomide, and glucocorticosteroids
- Documented progressive multiple myeloma per IMWG criteria
You will not qualify if you...
- History of intolerance to any study drugs
- Presence of amyloidosis, POEMS syndrome, HIV infection, active hepatitis B or C, or significant cardiovascular disease including uncontrolled angina, severe arrhythmia, recent myocardial infarction within 6 months, or NYHA class ≥3 congestive heart failure
- Major surgery within 4 weeks prior to screening
- Acute infections requiring intravenous therapy within 14 days prior to screening
- Uncontrolled diabetes or hypertension within 14 days prior to screening
- Any other medical condition that could affect study participation as judged by the investigator
- History of other active malignancies within past 3 years except certain treated cancers
- Evidence of ongoing graft-versus-host disease after prior allogeneic stem cell transplant
- Pregnant or breastfeeding women
- Hypersensitivity to study medications or their components
- Treatment with anti-CD38 antibodies within last 3 weeks or without at least minimal response
- Prior treatment with venetoclax
- Recent chemotherapy, corticosteroids (>20 mg prednisone or equivalent), immunotherapy, or proteasome inhibitors within 3 weeks
- Extensive radiation therapy within 28 days; localized radiation allowed
- Use of any other experimental drugs within 28 days
- Use of moderate or strong CYP3A inhibitors or inducers within 7 days
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to first dose
- Use of certain anticancer biologic agents within 21 days prior to first dose
- Concomitant medications requiring dose adjustments or exclusions such as warfarin and certain enzyme substrates or inhibitors
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Berenson Cancer Center
West Hollywood, California, United States, 90069
Actively Recruiting
2
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
Research Team
R
Richard Bailey
CONTACT
Y
Yohana Sebhat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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