Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pomalidomide; Thalidomide

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.