Trial · NCT05408026
Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM
NCT05408026, Phase 1, Phase 2, Withdrawn, Alliance Foundation Trials, LLC.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM. Trials, record NCT05408026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05408026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM
- NCT number
- NCT05408026
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- Daratumumab, Pomalidomide
- First posted
- 2022-06-07
- Last updated
- 2023-01-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Run-In Stage: Adverse events (AEs) will be assigned a grade and attribution using CTCAE v5.0 to determine the presence of dose-limiting toxicities (DLT). | 4-9 months | DLTs will be used to assess the safety profile \& determine tolerability of PVD-DARA in patients with RRMM. A DLT is the occurrence of any below toxicity during the first cycle probably, possibly or definitely related to study treatment: * Grade 4 neutropenia * Febrile neutropenia * Grade 4 thrombocytopenia * Grade 3 thrombocytopenia w/ bleeding * Grade 4 anemia, unexplained by underlying disease * Any non-hematological toxicity Grade ≥ 3, except: * Alopecia * Grade 3 nausea/vomiting/diarrhea for \< 72 hours w/ antiemetic \& other supportive care * Grade 3 fatigue for \< 1 week * Grade ≥ 3 isolated electrolyte abnormalities for ≤ 72 hours, not clinically complicated, resolve spontaneously/respond to conventional medical interventions * Grade ≥ 3 amylase/lipase elevation not associated w/ symptoms/clinical manifestations of pancreatitis * Grade 3 tumor lysis syndrome for ≤ 72 hours, not clinically complicated, resolves spontaneously/responds to conventional medical intervention |
| Primary | Phase II: To estimate the rate of Very Good Partial Response (VGPR) or better after 8 cycles of the combination PVD-DARA in patients with RRMM, including those with prior exposure to daratumumab | 36 months | To estimate the rate of VGPR or better after 8 cycles of the combination PVD-DARA in patients with RRMM, including those with prior exposure to daratumumab |
| Secondary | Rate of Adverse Events Grade ≥ 3 [Toxicity Profile] | 4 years | The toxicity profile will be summarized by determining the rate of patients with a grade 3 or higher adverse event. |
| Secondary | Rate of Dose Omission [Toxicity Profile] | 4 years | The toxicity profile will be summarized by determining the rate of patients at least one omitted dose. |
| Secondary | Rate of Dose Modification [Toxicity Profile] | 4 years | The toxicity profile will be summarized by determining the rate of patients at least one modified dose. |
| Secondary | To determine the overall response rate (ORR, including sCR, CR, VGPR, PR) after 8 cycles of the combination PVD-DARA in patients with RRMM, including patients previously exposed to daratumumab | 4 years | To determine the overall response rate (ORR, including sCR, CR, VGPR, PR) after 8 cycles of the combination PVD-DARA in patients with RRMM, including patients previously exposed to daratumumab |
| Secondary | To determine the Progression Free Survival (PFS) for the combination PVD-DARA in patients with RRMM, including patients previously exposed to daratumumab | 4 years | To determine the Progression Free Survival (PFS) for the combination PVD-DARA in patients with RRMM, including patients previously exposed to daratumumab |
| Secondary | To determine the overall survival for the combination PVD-DARA in patients with RRMM, including patients previously exposed to daratumumab | 4 years | To determine the overall survival for the combination PVD-DARA in patients with RRMM, including patients previously exposed to daratumumab |
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/NCT05408026
GET https://conductscience.org/api/trials/v1/NCT05408026/registered