Trial · NCT04775550
DARA RVD For High Risk SMM
NCT04775550, Phase 2, Active not recruiting, Omar Nadeem, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DARA RVD For High Risk SMM. Trials, record NCT04775550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04775550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DARA RVD For High Risk SMM
- NCT number
- NCT04775550
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Omar Nadeem, MD
- Conditions
- High-risk Smoldering Multiple Myeloma, Multiple Myeloma
- Interventions
- Daratumumab, Bortezomib, Lenalidomide, Dexamethasone
- First posted
- 2021-03-01
- Last updated
- 2026-07-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of high risk smoldering multiple myeloma (SMM) patients who are MRD negative (MRD-) | 2 years | MRD negative disease (MRD-) is defined as zero residual sequence cells detected at a level of one million cells. At time of final analysis, the 2-year MRD- rate will be summarized as a proportion with a 90% exact binomial confidence interval |
| Secondary | Objective Response Rate | 2 Years | (partial response or better according to the modified IMWG criteria) and the proportion of patients with a MRD, CR, PR or MR will be reported by Arm with 90% exact binominal confidence interval (CI). |
| Secondary | Duration of Response | 2 Years | time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died). The Kaplan-Meier method will be used. |
| Secondary | Progression-free survival | 2 Years | (time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died). The Kaplan-Meier method will be used. |
| Secondary | Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0 | 2 Years | For toxicity reporting, all adverse events and laboratory abnormalities will be graded and analyzed using CTCAE version 4 |
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/NCT04775550
GET https://conductscience.org/api/trials/v1/NCT04775550/registered