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



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:January 7, 2013
End Date:May 1, 2022

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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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.


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.
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