Trial · NCT04643002
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
NCT04643002, Phase 1, Phase 2, Recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab in Combination With Novel Agents in RRMM - Master Protocol. Trials, record NCT04643002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04643002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
- NCT number
- NCT04643002
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 258 participants, estimated
- Lead sponsor
- Sanofi
- Conditions
- Plasma Cell Myeloma Refractory
- Interventions
- Isatuximab, Dexamethasone, Pomalidomide, Belantamab mafodotin, Pegenzileukin, SAR439459, Belumosudil, Evorpacept
- First posted
- 2020-11-24
- Last updated
- 2026-10-13
- Other registries' IDs
- eudract:2020-003024-16
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab | Through the end of cycle 1 (approximately 6 weeks) | Determination or confirmation of the dose will be based on: safety and tolerability in terms of TEAEs/SAEs, dose-limiting toxicity occurrence, and laboratory parameters available information on PK (if appropriate) and biomarkers. |
| Primary | Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better) | Up to approximately 28 months after the First patient in or scheduled assessment | VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging. |
| Primary | Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies | Up to approximately 28 months after the First patient in or scheduled assessment | ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 1 (dose finding, experimental substudies): ORR | Up to approximately 28 months after the First patient in or scheduled assessment | ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 2 (expansion, controlled experimental substudies): ORR | Up to approximately 28 months after the First patient in or scheduled assessment | ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 1 (dose finding, experimental substudies): VGPR or better | Up to approximately 28 months after the First patient in or scheduled assessment | VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Part 2 (expansion, independent experimental substudies): VGPR or better | Up to approximately 28 months after the First patient in or scheduled assessment | VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Clinical benefit rate (CBR) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | CBR, defined as the proportion of participants with sCR, CR, VGPR, PR, or minimal response, according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging. |
| Secondary | Duration of Response (DOR) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | DOR, defined as the time from the date of the first response that is subsequently confirmed for patients achieving PR or better to the date of first documented PD or death, whichever happens first. |
| Secondary | Time to First Response (TT1R) in each treatment arm | Up to approximately 28 months after the First patient in or scheduled assessment | TT1R, defined as the time from the date of first treatment to the date of first response (PR or better) that is subsequently confirmed. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04643002
GET https://conductscience.org/api/trials/v1/NCT04643002/registered?page=2