Trial · NCT04653246
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
NCT04653246, Phase 2, Active not recruiting, Jacob Laubach, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM. Trials, record NCT04653246. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04653246
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM
- NCT number
- NCT04653246
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 52 participants, estimated
- Lead sponsor
- Jacob Laubach, MD
- Conditions
- Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM), Autologous Stem Cell Transplant
- Interventions
- Isatuximab, Lenalidomide, Bortezomib Injection, Dexamethasone
- First posted
- 2020-12-04
- Last updated
- 2026-04-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Very Good Partial Response (VGPR) | 84 days | proportion of patients who have achieved VGPR or better, according to International Myeloma Working Group (IMWG) criteria (Kumar 2016), by the end of two cycles of induction treatment |
| Secondary | Time to Progression | time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death up to 42 months | Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs). Time to progression is defined as time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death for those who died. |
| Secondary | Progression Free Survival | time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died up to 42 months | \- Progression-free survival (PFS) will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median Time to progression (TTP) with 95% confidence intervals (CIs Time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died |
| Secondary | Duration of Response | Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died up to 42 months | Duration of Response will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died. |
| Secondary | Overall Survival | Overall survival: time from registration to death from any cause or date last known alive for those who have not died up to 42 months | Overall Survival will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs Overall survival: time from registration to death from any cause or date last known alive for those who have not died |
| Secondary | Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0 | Induction to up to 3.5 years | Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) v5.0 |
| Secondary | stringent Complete Response (sCR) | 84 days | proportion of patients who have achieved sCR, according to IMWG criteria, by the end of two cycles of induction treatment. Response will be evaluated using a Simon optimal two-stage design. |
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/NCT04653246
GET https://conductscience.org/api/trials/v1/NCT04653246/registered