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

Description

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 and lenalidomide+/- dexamethasone combination therapy.

Study Start Date

December 2014

Estimated Completion Date

October 2023

Interventions

  • Drug: Elotuzumab
  • Drug: Lenalidomide
  • Drug: Dexamethasone

Specialties

  • Oncology: Myeloproliferative Dz,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Dexamethasone
  • Multiple Myeloma
  • Plasma Cell

Study ID

Dana-Farber Cancer Institute -- 14-338

Status

Recruiting

Trial ID

NCT02279394

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

82

Sponsor

Dana-Farber Cancer Institute

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
St Francis Hospital and Medical Center - Hartford, Connecticut 47.7 miles James Vredenburgh MD 860-714-7982 jvredenb@stfranciscare.org
Lawrence and Memorial Hospital - New London, Connecticut 60.4 miles None None None
NewtonWellesley Hospital - Newton, Massachusetts 132.4 miles Jeffrey Wisch MD 617-658-6000 jwisch@partners.org
Beth Israel Deaconess Medical Center - Boston, Massachusetts 135.7 miles Jacalyn Rosenblatt MD 617-632-4218 jrosenb1@bidmc.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 135.7 miles Irene Ghobrial MD 617-632-3352 Irene_Ghobrial@dfci.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 137.9 miles Andrew Yee MD 617-724-4000 ayee1@mgh.harvard.edu
Eastern Maine Medical Center - Brewer, Maine 336.2 miles Rodrigo Maegawa MD 207-973-7000 rmaegawa@emhs.org
Barbara Ann Karmanos Cancer Institute - Detroit, Michigan 512.3 miles Divaya Bhutani MD 313-576-8724 bhutanid@karmanos.org
Colorado Blood Cancer Institute - Denver, Colorado 1,665.3 miles Jeffrey Matous MD None Jeffrey.Matous@HealthONECares.com

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.