Trial · NCT04140162
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
NCT04140162, Phase 2, Active not recruiting, University of Michigan Rogel Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy. Trials, record NCT04140162. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04140162
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
- NCT number
- NCT04140162
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab, Lenalidomide, Bortezomib, Dexamethasone
- First posted
- 2019-10-25
- Last updated
- 2026-07-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Who Achieve MRD Negativity Either After Induction or, if Still MRD-positive After Induction, After Consolidation. | At the end of week 36 (post-consolidation therapy) | Of participants who complete at least one cycle of induction therapy, proportion that achieve MRD-negativity after completion of induction + those who achieve MRD-negativity after completion of consolidation (if still MRD-positive after induction). MRD status determined by International Myeloma Working Group (IMWG) Response Criteria. |
| Secondary | Overall Survival (OS) | Up to 3 years after start of study treatment | Time from initiation of daratumumab-based combination regimen until death or last follow-up date (whichever occurs first). |
| Secondary | Progression-free Survival (PFS) | Up to 3 years after start of study treatment | Time from initiation of daratumumab-based combination regimen to disease progression, where disease progression is according to the IMWG criteria, death, or last disease evaluation before the start of any subsequent anti-myeloma therapy (whichever occurs first). |
| Secondary | Proportion of Participants Who Were MRD-positive After Induction and Subsequently Achieve MRD-negative After Consolidation. | At the end of week 36 (post-consolidation therapy) | Of participants who are still MRD-positive after induction, proportion that achieve MRD-negative after consolidation. Per IMWG Response Criteria |
| Secondary | Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation | At the end of week 36 (post-consolidation therapy) | Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of consolidation therapy. |
| Secondary | Proportion of Participants Who Maintain Post-induction MRD-negativity to Post-consolidation. | At the end of week 88 (post 1 year of maintenance therapy) | Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity through completion of 1 year of maintenance therapy. |
| Secondary | Proportion of Participants Who Maintain Post-induction MRD-negativity to Last Follow-up Visit. | After week 88, up to 3 years after start of study treatment | Of participants who achieve post-induction MRD-negativity, proportion that maintain MRD-negativity until last follow-up visit (if after week 88). |
| Secondary | Health-related Quality of Life Assessment Changes From Baseline Using EuroQol Survey "EQ-5D." | Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d) | EQ-5D is a standardized participant-reported outcome measure developed by the EuroQol Group and used in this trial to assess health-related quality of life. |
| Secondary | Neurotoxicity Assessment Changes From Baseline Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Questionnaire. | Baseline to 16 weeks post-last-dose of study treatment (Dara, R, V or d) | The FACT/GOG-Ntx is a patient-reported outcome measure used to assess health-related quality of life in patients undergoing cancer therapy, plus an eleven-item subscale (Ntx subscale) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. |
| Secondary | Incidence of Treatment-emergent Adverse Events | From start of study treatment (Dara-Rd) up to 30 days post last dose of study treatment (Dara, R, V or d) | Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT04140162
GET https://conductscience.org/api/trials/v1/NCT04140162/registered