Trial · NCT04700176
A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma
NCT04700176, Phase 2, Terminated, Hackensack Meridian Health; results first posted 2025-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma. Trials, record NCT04700176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04700176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma
- NCT number
- NCT04700176
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Hackensack Meridian Health
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab, Pomalidomide, All-trans retinoic acid, Dexamethasone
- First posted
- 2021-01-07
- Last updated
- 2025-02-25
- Results first posted
- 2025-02-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (Cohort A) | 12 Months | To determine the ORR of the combination of Dara + Pom + Dex + ATRA in patients progressing on Dara + Len + Dex (Cohort A) |
| Primary | Incidence of Adverse Events | 12 Months | Incidence of Adverse Events in the combination of Dara + Pom + Dex + ATRA using CTCAE V5 criteria. |
| Secondary | Objective Response Rate (Cohort B) | 12 Months | To determine the ORR of the combination of Dara + Pom + Dex + ATRA in patients progressing on Dara + Pom + Dex |
| Secondary | Rate of Stringent Complete Response | 12 Months | To determine the best stringent complete response (sCR)/CR/near CR (nCR) and \>/= very good partial response (VGPR) rates. |
| Secondary | Incidence of Treatment-Emergent Adverse Events | 12 Months | To define the toxicity using CTCAE V5 criteria. |
| Secondary | Rate of Minimal Residual Disease Evaluation | 12 Months | To evaluate the status of minimal residual disease (MRD) in patients who achieve sCR, CR, or nCR. |
| Secondary | Time on Study (TOS) | 12 Months | Duration from start of study treatment to end of study |
| Secondary | Duration of Response (DOR) | 12 Months | Duration from treatment response to progression |
| Secondary | Time To Progression (TTP) | 12 Months | Duration from start of study treatment to progression |
| Secondary | Progression-Free Survival (PFS) | 12 Months | Duration from start of study treatment to PD or death \[regardless of cause\], whichever comes first |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (Cohort A) | 12 Months | No patients enrolled in Cohort B | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Adverse Events | 12 Months | No participants enrolled in cohort B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (Cohort B) | 12 Months | No participants enrolled in cohort B | ||
| SECONDARY | Rate of Stringent Complete Response | 12 Months | No participants enrolled in cohort B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Treatment-Emergent Adverse Events | 12 Months | No participants enrolled in cohort B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Minimal Residual Disease Evaluation | 12 Months | No participants enrolled in cohort B | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time on Study (TOS) | 12 Months | Patient withdrew consent to follow up at time of progression. No participants enrolled in cohort B | Months | NUMBER |
| SECONDARY | Duration of Response (DOR) | 12 Months | No participants enrolled in cohort B | Months | NUMBER |
| SECONDARY | Time To Progression (TTP) | 12 Months | No participants enrolled in cohort B | Months | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | 12 Months | No participants enrolled in cohort B | Months | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (Cohort A) | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | Participants | ||
| Objective Response Rate (Cohort A) | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | Participants | ||
| Incidence of Adverse Events | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | Participants | ||
| Incidence of Adverse Events | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | Participants | ||
| Rate of Stringent Complete Response | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 0 | Participants | ||
| Rate of Stringent Complete Response | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | Participants | ||
| Incidence of Treatment-Emergent Adverse Events | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | Participants | ||
| Incidence of Treatment-Emergent Adverse Events | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | Participants | ||
| Rate of Minimal Residual Disease Evaluation | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 0 | Participants | ||
| Rate of Minimal Residual Disease Evaluation | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | |
| Overall Study | STARTED | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | |
| Overall Study | COMPLETED | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | |
| Overall Study | COMPLETED | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | |
| Overall Study | NOT COMPLETED | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 0 | |
| Overall Study | NOT COMPLETED | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Brain Fogginess | Nervous system disorders | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 | 1 |
| other | Brain Fogginess | Nervous system disorders | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 | 0 |
| other | Constipation | Gastrointestinal disorders | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 | 1 |
| other | Constipation | Gastrointestinal disorders | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 | 0 |
| other | Constipation Intermittent | Gastrointestinal disorders | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 | 1 |
| other | Constipation Intermittent | Gastrointestinal disorders | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 | 0 |
| other | COVID-19 | Infections and infestations | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 | 2 |
| other | COVID-19 | Infections and infestations | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 | 0 |
| other | Dry Skin | Skin and subcutaneous tissue disorders | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 | 1 |
| other | Dry Skin | Skin and subcutaneous tissue disorders | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 0 | 1 |
| Total, all-cause mortality | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 |
| Total, other adverse events | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 |
| Total, other adverse events | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 |
| Total, serious adverse events | Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 | 1 |
| Total, serious adverse events | Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 | 0 |
Source ClinicalTrials.gov
Papers18
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/NCT04700176
GET https://conductscience.org/api/trials/v1/NCT04700176/events?page=2