Study of Natalizumab in Relapsed/Refractory Multiple Myeloma

NCT ID: NCT00675428

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Natalizumab 300 mg

Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.

Group Type: EXPERIMENTAL

BG00002 (natalizumab)

Intervention Type: DRUG

Natalizumab 450 mg

Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.

Group Type: EXPERIMENTAL

BG00002 (natalizumab)

Intervention Type: DRUG

Interventions

BG00002 (natalizumab)

Intervention Type: DRUG

Other Intervention Names

Tysabri

Eligibility Criteria

Inclusion Criteria

• Relapsed or refractory multiple myeloma that was treated with or was considered inappropriate for treatment with bortezomib and an IMiD® drug (including an analogue).
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.
• Corrected calcium <10.6 mg/dL.

Exclusion Criteria

• Candidates for stem cell transplantation willing to undergo transplantation. (Subjects who are candidates for stem cell transplantation, but are not willing to undergo transplant will be eligible for the study.)
• Autologous stem cell transplantation <3 months post-transplant.
• Prior allogeneic stem cell transplantation.
• Nonsecretory myeloma.
• Plasma cell leukemia (>2000/µL circulating plasma cells by standard cell counting differential), hyperleukocytosis (white blood cells >100,000/µL), clinical evidence of hyperviscosity syndrome, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), or primary systemic amyloidosis.
• Subjects who cannot undergo a brain magnetic resonance imaging (MRI) study.
• Clinically significant (as determined by the Investigator) 12 lead electrocardiogram (ECG) abnormalities, including QTc prolongation (>450 ms in males, >470 ms in females).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Center

Scottsdale, Arizona, United States

Research Center

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

101MY201

Identifier Type: -

Identifier Source: org_study_id