Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00722488|
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : November 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies Multiple Myeloma Lymphoma Hodgkin Lymphoma||Drug: MLN4924||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma|
|Study Start Date :||June 2008|
|Primary Completion Date :||July 2013|
|Study Completion Date :||September 2013|
Intravenous dose 100 mg/m2 on a Days 1,4,8,11 schedule within a 21-day treatment cycle. Treatment may continue until disease progression or unacceptable toxicity develops.
- Evaluation of safety and tolerability [ Time Frame: 12 months (maximum duration of therapy) ]
- Disease response [ Time Frame: 12 months (maximum duration of therapy) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722488
|United States, Georgia|
|Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|