Conditions: Multiple Myeloma
Keywords: Myeloma Multiple Myeloma Relapsed Multiple Myeloma Relapsed and Refractory Multiple Myeloma Refractory Myeloma Resistant Multiple Myeloma Treatment-resistant Multiple Myeloma Pomalidomide Lenalidomide-resistant Bortezomib-resistant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 455
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

Detailed description:

Arms:
arm 1: Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression. arm 2: Participants received 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day treatment cycle until disease progression.

Interventions: intervention 1: pomalidomide intervention 2: Dexamethasone
Intervention descriptions: intervention 1: 4 mg pomalidomide capsules administered orally intervention 2: 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally

Protocol document: