A Phase 1/2, Two-Arm, Dose-Finding Study of Natalizumab for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma.
- Age >/=18 years at the time of informed consent
- Relapsed or refractory multiple myeloma that was treated with or was considered
inappropriate for treatment with bortezomib and an IMiD drug (including an analogue).
- ECOG Performance Status =2.
- Corrected calcium <10.6 mg/dL
- 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.
- Non secretory myeloma.
- Plasma cell leukemia (>2000/uL circulating plasma cells by standard cell counting
differential), hyperleukocytosis (white blood cells >100,000/uL, clinical evidence of
hyperviscosity syndrome, POEMS (polyneuropathy, organomegaly, endocrinopathy,
monoclonal gammopathy, and skin changes syndrome), or primary systemic amyloidosis.
- Subjects who cannot undergo a brain MRI study.
- Clinically significant (as determined by the Investigator) 12 lead electrocardiogram
(ECG) abnormalities, including QTc prolongation (>450 ms in males; >470 ms in