Study of Natalizumab in Relapsed/Refractory Multiple Myeloma

Biogen

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: BG00002 (natalizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675428

101MY201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Natalizumab 300 mg

Experimental group

Description:

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

Treatment:

Drug: BG00002 (natalizumab)

Natalizumab 450 mg

Experimental group

Description:

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

Treatment:

Drug: BG00002 (natalizumab)