Trial · NCT04850599
Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT04850599, Phase 2, Active not recruiting, OHSU Knight Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma. Trials, record NCT04850599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04850599
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab, Carfilzomib, and Pomalidomide for the Treatment of Relapsed or Refractory Multiple Myeloma
- NCT number
- NCT04850599
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
- Carfilzomib, Isatuximab, Pomalidomide
- First posted
- 2021-04-20
- Last updated
- 2026-07-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | Up to end of cycle 4 (each cycles is 28 days), disease progression, start of new anti-myeloma therapy, or death (whichever occurs first) | Defined as the proportion of participants who achieve a response \>= partial response (PR) (i.e., PR, very good partial response, complete response, or stringent complete response) according to International Myeloma Working Group criteria. ORR will be measured from start of study treatment (i.e., cycle 1 day 1) to the earliest of the following events: end of cycle 4, start of new anti-myeloma therapy, documented disease progression, or death. Will be evaluated using the response-evaluable analysis set. A point estimate and exact 95% confidence interval will be provided. |
| Secondary | Incidence of grade > 2 toxicities | Up to 30 days after discontinuing study treatment | Evaluated per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Descriptive statistics will be used to summarize all on-study adverse events (AEs), grade 3-4 AEs, treatment-related AEs, grade 3-4 treatment-related AEs, SAEs, treatment-related severe (S)AEs, and AEs leading to study therapy discontinuation. Grade 3-4 laboratory abnormalities will be summarized using worst grade NCI CTCAE v5.0 criteria. |
| Secondary | Duration of response (DOR) | From initial disease response (>= PR) until disease progression, disease-related death, death from other cause (competing risk), or end of follow-up (censored), whichever occurs first, assessed up to 24 months | Defined for participants with a confirmed response (\>= PR) as the time between first documentation of response and disease progression according to IMWG criteria or death due to disease, whichever occurs first. Will be analyzed using the response-evaluable analysis set. Since non-progression, non-multiple myeloma (MM)-related death is a competing risk when assessing DOR, this endpoint will be estimated by cumulative incidence functions (one for progression or MM-related death, one for non-progression death) and modeled with Fine-Gray sub-distribution hazard regression. |
| Secondary | Time to next treatment | From start of study regimen until start of new anti-myeloma therapy, death from any cause before new therapy, or end of follow-up (censored), whichever occurs first, assessed up to 24 months | Will be estimated by the Kaplan-Meier method and modeled with Cox regression. |
| Secondary | Progression-free survival | From start of study treatment until disease progression, death, or end of follow-up (censored), whichever occurs first, assessed up to 24 months | Will be analyzed using the response-evaluable analysis set. Will be estimated by the Kaplan-Meier method and modeled with Cox regression. |
| Secondary | Overall survival | From start of study treatment until death or last known alive (censored), assessed up to 24 months | Will be estimated by the Kaplan-Meier method and modeled with Cox regression. |
| Other | Frequency of minimal residual disease negative remissions at time of complete response | First post-baseline bone marrow or aspirate until last standard of care bone marrow biopsy on study (including follow-up), assessed up to 24 months |
Source ClinicalTrials.gov
Outcomes0
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/NCT04850599
GET https://conductscience.org/api/trials/v1/NCT04850599/registered