Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)
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|ClinicalTrials.gov Identifier: NCT01712789|
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : January 10, 2022
Last Update Posted : January 10, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Pomalidomide Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||682 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 6, 2012|
|Actual Primary Completion Date :||December 11, 2019|
|Actual Study Completion Date :||December 11, 2019|
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 cycle
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.
- Number of Participants With Treatment Emergent Adverse Events (TEAE) [ Time Frame: From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks. ]
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.
A SAE = AE occurring at any dose that:
- Results in death;
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Overall Response [ Time Frame: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks ]Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions
- Time to Response [ Time Frame: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks ]Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.
- Kaplan Meier Estimate of Duration of Response [ Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months ]Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.
- Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines [ Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months ]Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.
- Kaplan Meier Estimate of Time to Progression [ Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months ]Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).
- Kaplan Meier Estimate of Overall Survival (OS) [ Time Frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months ]Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.
- Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F) [ Time Frame: Cycles 1, 2, 3, 4, 5, 6 ]Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.
- Pomalidomide Exposure - Apparent Volume of Distribution (V/F) [ Time Frame: Cycles 1, 2, 3, 4, 5, 6 ]Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
- Cytogenetic Analysis [ Time Frame: Study entry ]Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712789
|Study Director:||Teresa Peluso, MBBS, DCPSA||Bristol-Myers Squibb|