Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma
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
1 other identifier
interventional
56
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2008
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedNovember 18, 2013
November 1, 2013
5.1 years
July 23, 2008
November 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of safety and tolerability
12 months (maximum duration of therapy)
Secondary Outcomes (1)
Disease response
12 months (maximum duration of therapy)
Study Arms (1)
1
EXPERIMENTALMLN4924
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Related Publications (1)
Faessel HM, Mould DR, Zhou X, Faller DV, Sedarati F, Venkatakrishnan K. Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies. Br J Clin Pharmacol. 2019 Nov;85(11):2568-2579. doi: 10.1111/bcp.14078. Epub 2019 Sep 4.
PMID: 31355467DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
November 18, 2013
Record last verified: 2013-11