JPRN-jRCT2031220425
Recruiting
Phase 3
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)
Tanaka Tomoyuki0 sites534 target enrollmentOctober 29, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tanaka Tomoyuki
- Enrollment
- 534
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor, and with 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\))
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •\- Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2
- •\- Primary refractory multiple myeloma participants
- •\- Participants refractory to anti\-CD38 with a wash\-out period inferior to 9 months or intolerant to anti\-CD38 mAb agents
- •\- Prior therapy with pomalidomide
- •\- Participants with inadequate biological tests.
- •\- Significant cardiac dysfunction
- •\- Participants diagnosed or treated for another cancer within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
- •\- Concomittant plasma cell leukemia
- •\- Active primary amyloid\-light (AL) amyloidosis
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
SC versus IV isatuximab in combination with pomalidomide and dexamethasone in RRMMCancer - Plasma cell myeloma recurrentMedDRA version: 20.0Level: PTClassification code: 10073133Term: Plasma cell myeloma recurrent Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]CTIS2023-508869-32-00Sanofi-Aventis Recherche & Developpement606
Active, not recruiting
Phase 1
Phase 3 study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-002485-41-NOSanofi-aventis recherche & developpement614
Active, not recruiting
Phase 1
Phase 3 study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-002485-41-SESanofi-aventis recherche & developpement614
Active, not recruiting
Phase 1
Phase 3 study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-002485-41-HUSanofi-aventis recherche & developpement534
Active, not recruiting
Phase 1
Phase 3 study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM)EUCTR2021-002485-41-DESanofi-aventis recherche & developpement614