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SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients

NCT02283775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-07-09

No results posted yet for this study

Summary

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).

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

Isatuximab SAR650984

Pharmaceutical form:solution for infusion Route of administration: intravenous

DRUG

Pomalidomide

Pharmaceutical form:capsules Route of administration: oral

DRUG

Dexamethasone

Pharmaceutical form:tablets or solution for infusion Route of administration: oral or intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2021-05-26
Completion
2021-05-26

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02283775 on ClinicalTrials.gov