Trial · NCT04458831
A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
NCT04458831, Completed, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM). Trials, record NCT04458831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04458831
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
- NCT number
- NCT04458831
- Status
- Completed
- Enrollment
- 583 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Plasma Cell Myeloma
- Interventions
- isatuximab SAR650984, Pomalidomide, Dexamethasone, Carfilzomib
- First posted
- 2020-07-07
- Last updated
- 2026-07-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | 12 months | The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by investigator using the IMWG response criteria |
| Primary | Progression free survival (PFS) | Up to 30 months | Time from isatuximab start date to the date of first documentation of progressive disease (PD) (as determined by the investigator) or the date of death from any cause, whichever comes first. |
| Primary | Progression free survival rate (PFSR) | up to 18 months | The proportion of patients who do not progress and are alive at a specific time intervals |
| Primary | Duration of response (DoR) | Up to 30 months | Time from the date of the first response for patients achieving partial response (PR) 4 or better (PR, VGPR, CR, or sCR) to the date of first documented PD (as determined by Investigator using the IMWG response criteria) or death, whichever happens first. |
| Primary | Time to response (TTR) | Up to 30 months | Defined as the time between isatuximab start date and the onset of first response for patients achieving PR or better (sCR, CR, VGPR, or PR) assessed by investigator using the IMWG response criteria |
| Primary | Time to first subsequent anti-myeloma therapy | Up to 30 months | Time from the initiation of isatuximab until the start of subsequent therapy or death. |
| Primary | Rate of very good partial response or better | 12 months | Comprising VGPR, CR, and sCR within 12 months |
| Primary | Rate of complete response (CR) or better | 12 months | Comprising CR and sCR responses within 12 months |
| Primary | Number of Participants with Adverse events | Up to 1 month after the end of treatment | Adverse events (AE) including treatment emergent adverse events (TEAE), serious adverse events (SAE) and adverse events of special interest (AESIs) according to the following parameters: infusion associated reactions (IARs), pregnancy in a patient (or partner of a patient), symptomatic overdose, occurrence of a second primary malignancy, and/or neutropenia. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the TEAE period infusion |
| Primary | Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the Quality of Life 30 item core questionnaire (QLQ-C30) | through end of treatment (up to approximately 2 years) | EORTC QLQ-MY20 standardized scores: The EORTC QLQ-C30 is a brief self- or interviewer-administered patient-reported survey. This 30-item questionnaire measures the following domains: 1) global health status/QoL; 2) functional scales including physical, role, emotional, cognitive, and social functioning; and 3) symptom scales/items related to fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT04458831
GET https://conductscience.org/api/trials/v1/NCT04458831/registered