Trial · NCT05704049
A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT05704049, Phase 2, Active not recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma. Trials, record NCT05704049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05704049
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
- NCT number
- NCT05704049
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 118 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- Isatuximab, Carfilzomib, Dexamethasone, Dexamethasone IV, Montelukast, Acetaminophen, Diphenhydramine, Methylprednisolone
- First posted
- 2023-01-30
- Last updated
- 2025-12-29
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) - Cohorts 1 to 3 | 6 months after the Last Participant In (LPI) i.e., approximately 16 months | ORR defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria assessed by Independent Review Committee (IRC). |
| Primary | Maximum observed concentration (Cmax) over Cycle 1- Cohorts 4 to 5 | Cycle 1 (28 days) | |
| Primary | Cumulative area under the curve over the first 4 weeks (AUC4weeks) of isatuximab treatment- Cohorts 4 to 5 | Cycle 1 (28 days) | |
| Secondary | Proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6 | 6 months from LPI i.e., approximately 16 months | Patient preference for method of administration defined as the proportion of participants preferring OBDS over manual administration of isatuximab SC at Day 15 of Cycle 6 using the patient experience and satisfaction questionnaire version 2 (PESQ v2). |
| Secondary | Incidence rate of infusion reactions (IRs) | From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months | |
| Secondary | Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in laboratory parameters | From the signing of the informed consent to 30 days following the last administration of any study treatment i.e., up to approximately 45 months | |
| Secondary | Incidence rate of injection site reactions (ISRs) | 18 months after LPI i.e., approximately 28 months | |
| Secondary | PK concentration: trough plasma concentration (Ctrough) | Cycle 2 Day 1 and Cycle 6 Day 1 (1 Cycle = 28 days) | Blood samples will be collected for measurement of isatuximab concentrations. |
| Secondary | Overall response rate (ORR) | 6 months after the Last Participant In (LPI) i.e., approximately 16 months | Proportion of participants with sCR, CR, VGPR, and PR according to the 2016 IMWG criteria assessed by investigator. |
| Secondary | Duration of response (DOR) | 6 months after the Last Participant In (LPI) i.e., approximately 16 months | DOR defined as time from date of first IRC-determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by IRC or death, whichever occurred first, for Cohorts 1 to 3. For Cohorts 4-5, the time from date of first investigator determined response for participants achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41455697 | DERIVED |
Source PubMed
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/NCT05704049
GET https://conductscience.org/api/trials/v1/NCT05704049/registered