RecruitingMultiple Myeloma in RelapseMultiple Myeloma, Refractory
A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma
Eligible age
All ages
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
A phase 2 study of venetoclax in combination with isatuximab and dexamethasone for relapsed/refractory multiple myeloma patients with t(11;14)
Sponsor: Oncotherapeutics
You may qualify if…
- ✓ Subjects must meet all the following inclusion criteria to be eligible to enroll in this study.
- ✓ 1.Has a diagnosis of MM based on standard criteria as follows: Myeloma Criteria: Must be At least 1 of 2
- ✓ 1. Clonal bone marrow plasma cells \>10%
- ✓ 2. Biopsy-proven bony or extramedullary plasmacytoma
- ✓ Active Myeloma criteria: Must Meet At Least ONE of the Following:
- ✓ Meet at least one of the sub-criteria for #1 Evidence of End Organ Damage (a, b, c, or d), OR Meet sub-criteria #2. 60% or greater bone marrow plasma cells, OR Meet sub-criteria #3 Serum free light chain ratio, OR Meet sub-criteria #4 More than one focal lesion on MRI \> 5mm in size.
- ✓ 1. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
- ✓ 1. Hypercalcemia: serum calcium \>0.25 mmol/L (\>1mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11mg/dL)
You may not qualify if…
- ✕ Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- ✕ 1. Participant has a history of intolerability to any of the study drugs
- ✕ 2. Participant has any of the following conditions: amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known human immunodeficiency viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of screening, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 3, Major surgery within 4 weeks prior to screening, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to screening, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to screening, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study
- ✕ 3. Participant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study
- ✕ 4. If participant had prior allogeneic stem cell transplant (SCT), participant has evidence of ongoing graft-versus-host disease (GvHD)
- ✕ 5. Participants that are pregnant or breast feeding
- ✕ 6. Participants with hypersensitivity to any study medications and/or their excipients
- ✕ 7. Treatment with an anti-CD38 antibody (daratumumab or isatuximab) within the last 3 weeks
Where it's recruiting
California
West Hollywood
Nebraska
Omaha
Source: ClinicalTrials.gov · NCT06115135 · last updated 2025-01-16