Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

• Status: Active, not recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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 receiving lenalidomide maintenance for each study arm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Bristol-Myers Squibb
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Elotuzumab; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)