EUCTR2021-002485-41-SE
Active, not recruiting
Phase 1
A randomized, Phase 3, open label study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM)
Sanofi-aventis recherche & developpement0 sites614 target enrollmentNovember 17, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- Sanofi-aventis recherche & developpement
- Enrollment
- 614
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with multiple myeloma who have received at least one
- •prior line of anti\-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination
- •\- measurable serum M\-protein (\= 0\.5 g/dL) and/or urine M\-protein (\=
- •200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved
- •FLC assay \=10 mg/dL and abnormal serum FLC ratio (\<0\.26 or \>1\.65\))
- •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 246
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria
- •\- Primary refractory multiple myeloma participants
- •\-Participants with prior anti\-CD38 treatment: (a) administered a less
- •than 9 months before randomization or, (b) intolerant to the anti\-CD38
- •previously received
- •\- Prior therapy with pomalidomide
- •\- Participants with inadequate biological tests.
- •\- Significant cardiac dysfunction
- •\- Participants diagnosed or treated for another malignancy within 3
- •years prior to randomization with the exception of complete resection of
Outcomes
Primary Outcomes
Not specified
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