Status:
TERMINATED
Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receivin...
Detailed Description
This is a randomized parallel 2-cohort phase 2 study of elotuzumab given at 10 mg/kg weekly during induction in combination with lenalidomide (either 25 mg or 10 mg) in patients with multiple myeloma ...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma who demonstrate evidence of serologic relapse/progression while on lenalidomide maintenance given as part of first line therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg PO daily for up to 28 days (28-day cycle).
- Male or female patients aged ≥ 18 years old
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Measurable disease as outlined in protocol guidelines
- Participants must meet laboratory criteria as outlined in protocol guidelines
Exclusion
- Prior Elotuzumab
- Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of the following criteria:
- Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression)
- Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and ≥1 cm) increase as measured serially of the measurable lesion
- Hypercalcemia (\>11 mg/dL);
- Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myeloma-related conditions;
- Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma
- Hyperviscosity related to serum paraprotein
- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy testing within 7 days prior to the administration of drug.
- Male patients whose sexual partners are WOCBP not using effective birth control
- Patients with a prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
- Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03411031
Start Date
October 4 2018
End Date
November 4 2021
Last Update
March 29 2023
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612