EUCTR2020-003024-16-IT
Active, not recruiting
Phase 1
Phase 1-2 trial evaluating anti-TGFß agent (SAR439459) or pomalidomide in combination with isatuximab and dexamethasone in relapsed or refractory multiple myeloma (RRMM) - .
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 sites60 target enrollmentJune 4, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Participants who have received at least 3 prior lines of therapy for Multiple myeloma or at least 2 prior lines if at least one of these lines consisted of 2 or more multiagent regimens. Prior exposure to drugs targeting CD38 is allowed with a wash\-out of at least 6 months after the last dose.
- •\-Eastern Cooperative Oncology Group (ECOG) performance status 0\-1\.
- •\-measurable disease.
- •\-Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 24
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 36
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •\-Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to randomization.
- •\-Uncontrolled or active hepatitis B or C virus.
- •\-Malabsorption syndrome.
- •\-Any anti\-MM drug treatment within 14 days before randomization, including dexamethasone.
- •\-Inadequate organ functions.
- •\-Corrected serum calcium \>14 mg/dL (\>3\.5 mmol/L).
- •\-Sensitivity to any of the study interventions.
- •\-Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control.
Outcomes
Primary Outcomes
Not specified
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