Trial of Combination of Elotuzumab and Lenalidomide +/- Dexamethasone in High-Risk Smoldering Multiple Myeloma

Overview

This research study is a Phase II clinical trial, which tests the effectiveness of the investigational drugs elotuzumab, lenalidomide and dexamethasone in smoldering multiple myeloma. Recent research studies have shown that early treatment of smoldering multiple myeloma may delay or prevent the progression to active multiple myeloma. The purpose of this research study is to learn whether the combination of elotuzumab and lenalidomide or the combination of elotuzumab, lenalidomide and dexamethasone works in treating smoldering multiple myeloma.
SparkCures ID 658
Trial Phase Phase 2
Enrollment 82 Patients
Treatments
Trial Sponsors
  • Dana-Farber Cancer Institute
Trial Collaborators
  • Bristol-Myers Squibb
  • Celgene Corporation
NCT Identifier

NCT02279394

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Age ≥ 18 years
  • Must have smoldering myeloma with high risk markers based on the Mayo OR the Spanish criteria as described below
  • Monoclonal protein in the serum of ≥ 3 gm/dL and >10% plasma cells in the bone marrow with a free light chain ratio outside the range of 0.125 to 8 -- OR
  • Ratio or abnormal to normal bone marrow plasma cells greater than or equal to 95 percent or at least one immunoglobulin level lower than the normal range
  • No evidence of CRAB (see below for details) criteria or new criteria of active multiple myeloma which including the following
    • Increased calcium levels (corrected serum calcium >0.25 mmol/dL above the upper limit of normal or >.275 mmol/dL)
    • Renal insufficiency (attributable to myeloma)
    • Anemia (Hb 2g/dL below the lower limit of normal or <10g/dL)
    • Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)
    • No evidence of the following new criteria for active MM including the following: Bone marrow plasma cells ≥ 60%, Serum involved/uninvolved FLC ratio ≥100, and MRI with more than one focal lesion
  • ECOG Performance Status (PS) 0, 1, or 2 (Appendix A)
  • The following laboratory values obtained ≤ 14 days prior to registration:
    • ANC ≥1000/µL
    • PLT ≥ 50,000/µL
    • Total bilirubin ≤ 2.0 mg/dL (If total is elevated check direct and if normal patient is eligible.)
    • AST ≤ 3 x institutional upper limit of normal (ULN)
    • ALT ≤ 3 x institutional upper limit of normal (ULN)
    • Estimated creatinine clearance ≥ 60mL/min or a creatinine ≤ 2.2 mg/dL
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Females of childbearing potential* must have a negative serum or urine pregnancy test
  • Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy
  • Ability to understand and the willingness to sign a written informed consent.
  • Exclusion Criteria:
  • Symptomatic Multiple Myeloma or any evidence of CRAB criteria including the new criteria for overt myeloma. Any prior therapy for active Myeloma should also be excluded. Prior therapy for smoldering myeloma is not an exclusion criteria. Bisphosphonates are not excluded
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is allowed. Prior radiation therapy to a solitary plasmacytoma is allowed. Prior clinical trials for smoldering MM or MGUS are allowed as long as the last therapy was at least 2 months prior and there was no improvement in M spike
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Uncontrolled intercurrent illness
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to elotuzumab or lenalidomide
  • Known seropositive for or active viral infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus. Patients who are seropositive because of hepatitis B virus vaccine are eligible

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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