Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma

Launched by MILLENNIUM PHARMACEUTICALS, INC. · Jul 23, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• • Patients must have a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists.
• • 1. As of Protocol Amendment 7, patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma, DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with multiple myeloma will no longer be evaluated as a part of this study.
• • Tumor that is evaluable by radiography, serum or urine electrophoresis (for patients with multiple myeloma), or clinical evaluations.
• • 1. As of Protocol Amendment 7, tumor that is evaluable by radiography or clinical evaluations.
• • Suitable venous access for the conduct of blood sampling for MLN4924
• • Adequate Organ Function
• Exclusion Criteria:
• • Systemic antineoplastic therapy within 21 days preceding first dose of study treatment, or rituximab therapy within 2 months preceding first dose of study treatment (unless there was evidence of PD since their last dose of rituximab).
• • Treatment with corticosteroids within 7 days preceding first dose of study treatment.
• • Prior treatment with radiation therapy involving \>25% of bone marrow; Any radiotherapy within 14 days before first dose of study treatment.
• • Treatment with CYP3A inducers within 14 days before the first dose of MLN4924. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
• • Patients requiring Coumadin who cannot be switched to a low molecular weight heparin should not be considered for this study.
• • Absolute neutrophil count less than 1,000/mm3; platelet count less than 75,000/mm3.
• • Calculated creatinine clearance less than or equal to 50 mL/minute.