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
Public ClinicalTrials.gov record NCT01946477. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Multi-cohort, Open-label Study of 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01946477
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 186 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2014
- Primary completion
- Apr 29, 2025
- Completion
- May 25, 2025
- Last update posted
- Jun 14, 2026
2014 – 2025
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 126 | Tucson | Arizona | 85724 | — |
| Local Institution - 137 | Greenbrae | California | 94904-2007 | — |
| Local Institution - 109 | Los Angeles | California | 90095-1670 | — |
| Local Institution - 104 | Pleasant Hill | California | 94523 | — |
| Local Institution - 108 | Whittier | California | 90603 | — |
| Local Institution - 138 | Denver | Colorado | 80218 | — |
| Local Institution - 120 | Stamford | Connecticut | 06902 | — |
| Local Institution - 145 | Jacksonville | Florida | 32256 | — |
| Local Institution - 127 | Orlando | Florida | 32804 | — |
| Local Institution - 133 | Pembroke Pines | Florida | 33028 | — |
| Local Institution - 136 | St. Petersburg | Florida | 33705 | — |
| Local Institution - 134 | Fairway | Kansas | 66205 | — |
| Local Institution - 142 | Topeka | Kansas | 66606 | — |
| Local Institution - 124 | Louisville | Kentucky | 40207 | — |
| Local Institution - 103 | Westminster | Maryland | 21157 | — |
| Local Institution - 146 | Gross Pointe | Michigan | 48236 | — |
| Local Institution - 102 | Kansas City | Missouri | 64111 | — |
| Local Institution - 110 | St Louis | Missouri | 63110 | — |
| Local Institution - 118 | East Orange | New Jersey | 07018 | — |
| Local Institution - 101 | Hackensack | New Jersey | 07601 | — |
| Local Institution - 129 | Glens Falls | New York | 12801 | — |
| Local Institution - 149 | The Bronx | New York | 10467 | — |
| Local Institution - 130 | Durham | North Carolina | 27705 | — |
| Local Institution - 123 | Cleveland | Ohio | 44106 | — |
| Local Institution - 121 | Cleveland | Ohio | 44111 | — |
| Local Institution - 115 | Cleveland | Ohio | 44195 | — |
| Local Institution - 122 | Mayfield Heights | Ohio | 44124 | — |
| Local Institution - 107 | Hershey | Pennsylvania | 17033-0850 | — |
| Local Institution - 135 | Chattanooga | Tennessee | 37404 | — |
| Local Institution - 131 | Nashville | Tennessee | 37203 | — |
| Local Institution - 128 | Lubbock | Texas | 79410 | — |
| Local Institution - 143 | Plano | Texas | 75093 | — |
| Local Institution - 106 | Spokane | Washington | 99218 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01946477, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2026 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01946477 live on ClinicalTrials.gov.