Clinical trial NCT03411031: Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
Official title: A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: lenalidomide maintenance
hematopoietic cell transplantation
serologic relapse
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2018-01-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 receiving lenalidomide maintenance for each study arm.

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 who progress or relapse serologically while on single agent lenalidomide maintenance.

The combination therapy with elotuzumab and lenalidomide will be continued until further progression of myeloma (based on response criteria) or intolerability.

Eligibility 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)

Primary outcomes:
measure: Percentage of Participants With Progression Free Survival (PFS)
timeFrame: An average of 8 months
Secondary outcomes:
measure: Overall Response
timeFrame: Up to 60 days post last study treatment
measure: Minimum Response (MR)
timeFrame: Up to 60 days post last study treatment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Melissa Alsina, M.D.
role: PRINCIPAL_INVESTIGATOR
References: