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Trial · NCT04268498

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

NCT04268498, Phase 2, Active not recruiting, University of Miami

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma. Trials, record NCT04268498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04268498

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma
NCT number
NCT04268498
Status
Active not recruiting
Phases
Phase 2
Enrollment
310 participants, actual
Lead sponsor
University of Miami
Conditions
Multiple Myeloma
Interventions
Bortezomib, Dexamethasone, Lenalidomide, Acetaminophen, Diphenhydramine, Montelukast, Carfilzomib, Daratumumab, Autologous Stem Cell Transplant (ASCT)
First posted
2020-02-13
Last updated
2026-03-24
Other registries' IDs
eudract:2019-001645-41

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of Minimal Residual Disease (MRD) NegativityUp to 32 weeksMRD will be assessed by the MRD scale ranging from 10 (increased disease detection) to -5 (less to no disease detection) after 8 cycles of therapy.
SecondaryOverall SurvivalUp to 16 weeksOverall survival is defined as the time from date of randomization to death from any cause
SecondaryProgression Free Survival (PFS)Up to 16 weeksPFS is defined as time from date of randomization to time of progression or death, whichever occurs first.
SecondaryEvent Free Survival (EFS)Up to 16 weeksEFS is defined as time from date of randomization to the time of 1) achieving a PR or less with the first four cycles of therapy, 2) transplant, 3) progression, or 4) death, whichever occurs first.
SecondaryRate of ResponseUp to 3 years
Rate of Response will be reported as the percentage of participants achieving a response of: a) Partial Response (PR) or better, b) Very Good Partial Response (VGPR) or better and c) Complete Response (CR) and Stringent Complete Response (sCR). Responses will be evaluated from participant serum, urine and bone marrow samples.
SecondaryRate of MRD Negativity as best responseUp to 3 yearsMRD will be evaluated from bone marrow samples.
SecondaryIncidence of treatment related toxicityUp to 9 monthsToxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
SecondaryMinimal Residual Disease (MRD) NegativityUp to 3 yearsMRD Negativity using bone marrow and blood samples

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT04268498

GET https://conductscience.org/api/trials/v1/NCT04268498/registered