Multiple Myeloma
Conditions
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At least 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination Documented refractory or relapsed and refractory multiple myeloma Refractory to proteosome inhibitor and lenalidomide, and to last treatment Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment Measurable disease at screening Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion criteria
Exclusion criteria: Active plasma cell leukemia Prior treatment with pomalidomide Unable to tolerate thromboembolic prophylaxis while on the study Prior autologous stem cell transplant within 12 weeks Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression-free survival (PFS) PFS will be defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Objective Response Rate (ORR) Overall Survival (OS) - | — |
Countries
Japan
Outcome results
None listed