Phase 3
N=559
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01734928 ↗Enrolled (actual)
559
Serious AEs
54.0%
Results posted
Jun 2023
Primary outcome: Primary: Progression Free Survival by Independent Response Adjudication Committee (IRAC) — 11.20; 7.10 Months — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pomalidomide (Drug); Bortezomib (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival by Independent Response Adjudication Committee (IRAC) |
11.20; 7.10 | 0.001 sig |
| SECONDARY Overall Survival (OS) |
35.58; 31.61 | 0.571 |
| SECONDARY Overall Response Rate by Independent Response Adjudication Committee (IRAC) |
9; 2; 35; 9; 104; 40 | — |
| SECONDARY Duration of Response by Independent Response Adjudication Committee (IRAC) |
13.70; 10.94 | 0.064 |
| SECONDARY Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE) |
259; 194 | — |
| SECONDARY Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE) |
29; 12 | — |
Summary
The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.
Eligibility Criteria
Inclusion Criteria
- Must be ≥ 18 years at the time of signing informed consent.
- Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
- Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
- Must have documented disease progression during or after their last anti-myeloma therapy.
- All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.
Exclusion Criteria
- Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
- Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
- Non-secretory multiple myeloma.
- Subjects with severe renal impairment requiring dialysis.
- Previous therapy with pomalidomide.
Data sourced from ClinicalTrials.gov (NCT01734928). 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.