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Protocol No. S1211

Principal Investigator Callander, Natalie

Phase I/II

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)

Objective We want to find out if a drug called elotuzumab is safe to use to treat multiple myeloma.

Treatment Elotuzumab is an experimental drug. This means that elotuzumab has not been approved by the US Food and Drug Administration (FDA) for the treatment of multiple myeloma and can only be given in a research study.

Description One of the standard treatments for your type of cancer is the combination of bortezomib, lenalidomide and dexamethasone (RVD). Elotuzumab is an experimental cancer drug. It is currently being tested in cancer patients. There are laboratory results that suggest that RVD might work better if elotuzumab is added.

This study is being conducted in two parts: Part I and Part II. Part I determined the best dose of elotuzumab to use with RVD and is completed. If you take part in this study you will be in Part II.

Subjects in Part II of the study must have high risk myeloma. This means your myeloma is harder to treat. All subjects in this part of the study will be treated with RVD. About half of the subjects in this part will also get elotuzumab (at the dose decided in the first part of the study). This part of the study is being done to find out what effects, good and/or bad, adding elotuzumab to RVD has on myeloma. Click here for more info

Key Eligibility
  • Patients must have newly diagnosed active multiple myeloma(MM)
  • For Phase II portion only, patients must have high risk MM based on one or more of the following criteria at the time of initial diagnosis: poor risk genomic signature according to the University of Arkansas 70- gene model and/or translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by florescence in-situ hybridization (FISH) or cytogenetics and/or primary plasma cell leukemia (defined by either ≥ 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count and/or serum lactate dehydrogenase (LDH) ≥ 2 x Institutional Upper Limit of Normal (IULN) and/or 1q21 amplification by FISH analysis and/or high risk by the SKY92 signature
  • Patients with non-secretory MM or known amyloidosis are not eligible
  • Patients must have measurable disease as defined by Section 10.1a within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
  • Patients on the Phase I portion may not have received ANY prior chemotherapy
  • Patients on the Phase II portion may have received one prior cycle of any non- investigational chemotherapy. Prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to ≤ Grade 1
  • Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only
  • Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation)
  • Patients must be ≥ 18 years of age
  • Patients with known Hepatitis B or Hepatitis C infection may be eligible providing they have viral load < 800,000 IU/L within 28 days prior to registration
  • Patients must not have POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

Applicable Disease Sites Multiple Myeloma

Status Not Open