Trials / Completed
CompletedNCT01712789
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 682 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pomalidomide | Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle |
| DRUG | Dexamethasone | Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle. |
Timeline
- Start date
- 2012-11-06
- Primary completion
- 2019-12-11
- Completion
- 2019-12-11
- First posted
- 2012-10-24
- Last updated
- 2022-01-10
- Results posted
- 2022-01-10
Locations
112 sites across 20 countries: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01712789. Inclusion in this directory is not an endorsement.