Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Adverse Events [ Time Frame: Up to 5 years ]Number of participants with adverse events
- PK-Cmax [ Time Frame: Up to 5 years ]PK-Maximum Concentration in Plasma
- PK-AUC [ Time Frame: Up to 5 years ]PK-Area under the plasma concentration time curve
- PK-Cmin [ Time Frame: Up to 5 years ]PK-Minimum Concentration in Plasma
- Overall response rate [ Time Frame: Up to 5 years ]Rate of participants who responds to the study treatment
- Time to response [ Time Frame: Up to 5 years ]Time from study enrollment to first documented response
- Duration of response [ Time Frame: Up to 5 years ]Time from the treatment response until progression of Multiple Myeloma
- Progression-free survival [ Time Frame: Up to 5 years ]Time from enrollment until progression of Multiple Myeloma
- Time to progression [ Time Frame: Up to 5 years ]Time from study enrollment until progression to Multiple Myeloma
- Overall survival [ Time Frame: Up to 5 years ]Time from study enrollment to the death of the patient
- POM population pharmacokinetics and exposure-response [ Time Frame: During the first 6 cycles of treatment ]The key exposure data are serum drug concentration, Cmax, Cmin and AUC derived from the population PK analysis.
|Actual Study Start Date:||November 6, 2012|
|Estimated Study Completion Date:||December 11, 2019|
|Estimated Primary Completion Date:||December 11, 2019 (Final data collection date for primary outcome measure)|
Experimental: Pomalidomide plus Dexamethasone
Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycleDrug: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712789
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|Principal Investigator:||Nicolas Leupin, MD||Celgene Corporation|