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Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT04045795 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-09-12

No results posted yet for this study

Summary

Primary Objectives:

* To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
* To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
* To evaluate the pharmacokinetics (PK) of SC and IV isatuximab

Secondary Objectives:

* To estimate absolute bioavailability of SC and IV isatuximab
* To measure receptor occupancy (RO) after isatuximab SC versus IV administration
* To assess efficacy of isatuximab after SC and IV administration
* To assess patient expectations prior to and patient experience and satisfaction after SC administration
* To evaluate potential immunogenicity of SC or IV isatuximab

Conditions

Interventions

DRUG

isatuximab SAR650984 IV

Pharmaceutical form: solution Route of administration: intravenous

DRUG

pomalidomide

Pharmaceutical form: tablet Route of administration: oral

DRUG

dexamethasone

Pharmaceutical form: tablet Route of administration: oral

DRUG

isatuximab SAR650984 SC

Pharmaceutical form: solution Route of administration: subcutaneous

DEVICE

Investigational injector device

Subcutaneous administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-06
Primary Completion
2024-03-27
Completion
2024-03-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04045795 on ClinicalTrials.gov