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NCT01946477 · ClinicalTrials.gov registry record · Phase 2
Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 186
- Enrollment target
NCT01946477: Completed Phase 2 study, sponsored by Celgene.
NCT01946477 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 186 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01946477, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 186 participants
- Enrollment target
Study Summary
This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy. This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of \> 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of \> 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of \>60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.
Primary Outcome
ORR per Modified International Myeloma Working Group (mIMWG) Criteria is defined as the percentage of participants who achieve best overall response of Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR). CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum
Interventions
- DRUG Dexamethasone
- DRUG Daratumumab
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2014-05-29 |
| Est. Completion | 2025-05-26 |
| Phase | Phase 2 |
What the finished NCT01946477 record still lists
NCT01946477 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01946477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01946477 about?
NCT01946477 is a clinical study titled "Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting". This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma w...
What is the current status of trial NCT01946477?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2014-05-29. Estimated completion is 2025-05-26.
What interventions are being tested in trial NCT01946477?
The interventions under investigation include: Dexamethasone (DRUG), Daratumumab (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01946477?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01946477's enrollment target sits among peer trials
186 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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