E- PRISM: Precision Intervention Smoldering Myeloma: Phase II Trial of Combination of Elotuzumab, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Elotuzumab+Lenalidomide+Dexamethasone
Status: Active, not recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age ≥ 18 years

• Must have smoldering myeloma with high risk markers based on the Mayo OR the Spanish criteria as described below

• >10% plasma cells in the bone marrow and any one or more of the following:

• Serum M protein of 3 g/dL or greater

• IgA SMM

• Immunoparesis with reduction of two uninvolved immunoglobulin isotypes

• Serum involved/uninvolved free light chain ratio ≥8 (but less than 100)

• Progressive increase in M protein level (Evolving type of SMM)†

• Bone marrow clonal plasma cells 50-60%

• Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes

• t (4;14) or del 17p or 1q gain

• Increased circulating plasma cells

• MRI with diffuse abnormalities or 1 focal lesion

• PET-CT with focal lesion with increased uptake without underlying osteolytic bone destruction † Increase in serum monoclonal protein by ≥25% on two successive evaluations within a 6 month period

• 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

• Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible

• 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.

Locations
United States
Colorado
Colorado Blood Cancer Institute
Denver
Connecticut
St Francis Hospital and Medical Center
Hartford
Illinois
University of Chicago
Chicago
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Maryland
University of Maryland
Baltimore
Maine
Eastern Maine Medical Center
Brewer
Michigan
Barbara Ann Karmanos Cancer Institute
Detroit
North Carolina
Levine Cancer Institute
Charlotte
Time Frame
Start Date: December 11, 2014
Estimated Completion Date: October 2023
Participants
Target number of participants: 51
Treatments
Experimental: Elo / Len / Dex
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8~Other Name: HuLuc63~•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24~Other Name: REVLIMID~•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8~Other Name: Decadron
Experimental: Elo / Len
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8~Other Name: HuLuc63~•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24~Other Name: REVLIMID
Authors
Sponsors
Collaborators: Celgene, Blood Cancer Research Partnership, The Leukemia and Lymphoma Society, Multiple Myeloma Research Consortium, Bristol-Myers Squibb
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov

Similar Clinical Trials