Conditions: Multiple Myeloma
Keywords: Relapsed or refractory Multiple Myeloma
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
The primary objectives of the study are to evaluate the safety profile and the anti-tumor activity of 2 dose levels of natalizumab in participants with relapsed or refractory multiple myeloma. Secondary objectives are to assess the pharmacokinetic (PK) profile of natalizumab in this study population and to assess peripheral blood mononuclear cell (PBMC) saturation of very late antigen-4 (VLA-4, an α4-integrin) and evaluate possible correlations with clinical activity.

Detailed description:
Despite no protocol-defined study stopping criteria being met, the sponsor decided to terminate enrollment after the phase 1 portion was complete and to not move into the phase 2 portion of the study. This decision was made due to difficulty enrolling participants and was not due to any safety concerns.

Arms:
arm 1: Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months. arm 2: Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.

Interventions: intervention 1: BG00002 (natalizumab)
Intervention descriptions: intervention 1: None

Protocol document: