Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

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NCT04643002 · readout in 390 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

258estimated

Sites

Countries

Australia, France, Germany +7

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-01-25

actual

When the study began enrolling

Primary completion

2027-09-13

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-04-20

estimated

The whole study's end, after follow-up

First posted

2020-11-24

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-16

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Plasma Cell Myeloma Refractory

Interventions

Drug: Isatuximab — also filed as SAR650984, Sarclisa®
Drug: Dexamethasone
Drug: Pomalidomide — also filed as Pomalyst®
Drug: Belantamab mafodotin — also filed as BLENREP®
Drug: Pegenzileukin — also filed as SAR444245
Drug: SAR439459
Drug: Belumosudil — also filed as SAR445761,, Rezurock
Drug: Evorpacept — also filed as ALX148

Primary outcomes

what the primary-completion date above is the date OF

Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab

measured Through the end of cycle 1 (approximately 6 weeks)

Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)

measured Up to approximately 28 months after the First patient in or scheduled assessment

Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies

measured Up to approximately 28 months after the First patient in or scheduled assessment

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