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

Completed · Phase 1

Conditions studied: Hematologic Malignancies, Multiple Myeloma, Lymphoma, Hodgkin Lymphoma

In brief

This is an open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with lymphoma or multiple myeloma. The patient population will consist of adults with 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. 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.

Key facts

Study ID

NCT00722488

Run by

Millennium Pharmaceuticals, Inc.

People needed

56

Starts

2008-06-01

Expected to finish

2013-09-01

Last updated by the study team

2013-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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

You may not qualify if…

• 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.

Where it is running

• Winship Cancer Institute — Atlanta, Georgia, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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