SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients
Public ClinicalTrials.gov record NCT02283775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b Study of SAR650984 (Isatuximab) in Combination With Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: * To evaluate the infusion duration (Part B). * To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). * To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). * To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). * To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). * To assess the relationship between clinical effects (adverse event \[AE\] and/or tumor response) and CD38 receptor density at baseline (Part A).
Study identification
- NCT ID
- NCT02283775
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2015
- Primary completion
- May 25, 2021
- Completion
- May 25, 2021
- Last update posted
- Jul 8, 2021
2015 – 2021
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840001 | Scottsdale | Arizona | 85054 | — |
| Investigational Site Number 840006 | Duarte | California | 91010 | — |
| Investigational Site Number 840018 | New Haven | Connecticut | 06520-8017 | — |
| Investigational Site Number 840011 | Decatur | Illinois | 62526 | — |
| Investigational Site Number 840004 | Boston | Massachusetts | 02115 | — |
| Investigational Site Number 840104 | Boston | Massachusetts | 2114 | — |
| Investigational Site Number 840010 | Chapel Hill | North Carolina | 27599 | — |
| Investigational Site Number 840003 | Charlotte | North Carolina | 28204 | — |
| Investigational Site Number 840014 | Canton | Ohio | 44718 | — |
| Investigational Site Number 840016 | Charleston | South Carolina | 29425 | — |
| Investigational Site Number 840015 | Salt Lake City | Utah | 84112-5550 | — |
| Investigational Site Number 840005 | Seattle | Washington | 98108 | — |
| Investigational Site Number 840017 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02283775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02283775 live on ClinicalTrials.gov.