Phase 3
Completed N=682
Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT01712789 ↗Enrolled (actual)
682
Serious AEs
66.3%
Results posted
Jan 2022
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAE) — 673; 527; 448; 575 Participants
◆ Published Evidence
Highly cited
162citations · ~16 / year
Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma.
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.
Linked Publications (3)
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Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma.
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Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials.
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Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAE) |
673; 527; 448; 575; 606; 417 | — |
| SECONDARY Overall Response |
33.4 | — |
| SECONDARY Time to Response |
8.1 | — |
| SECONDARY Kaplan Meier Estimate of Duration of Response |
7.9 | — |
| SECONDARY Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines |
4.6 | — |
| SECONDARY Kaplan Meier Estimate of Time to Progression |
4.8 | — |
| SECONDARY Kaplan Meier Estimate of Overall Survival (OS) |
11.9 | — |
| SECONDARY Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F) |
6.02 | — |
| SECONDARY Pomalidomide Exposure - Apparent Volume of Distribution (V/F) |
75.10 | — |
| SECONDARY Cytogenetic Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.
- Patients must have documented diagnosis of Multiple Myeloma and have measurable disease.
- Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy.
- Patients must have either refractory or relapsed and refractory disease.
- Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens.
- Patients must have received adequate alkylator therapy
Exclusion Criteria
- Prior history of malignancies, other than Multiple Myeloma.
- Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone.
- Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant.
- Patients who are planning for or who are eligible for stem cell transplant.
- Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment.
- Patients with a current disease that can interfere with protocol procedures or study treatment.
- Patients unable or unwilling to undergo antithrombotic prophylactic treatment.
- Pregnant or breastfeeding females.
Data sourced from ClinicalTrials.gov (NCT01712789) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.