Status:
TERMINATED
Study of Natalizumab in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Biogen
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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. Seconda...
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....
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00675428
Start Date
September 1 2008
End Date
December 1 2009
Last Update
September 19 2014
Active Locations (2)
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1
Research Center
Scottsdale, Arizona, United States
2
Research Center
Rochester, Minnesota, United States