A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma

Celgene

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: CC-5013

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051116

CC-5013-MM-008

Details and patient eligibility

About

To evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• History of histologically documented multiple myeloma with relapsed or resistant disease
• Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)