Dendritic Cell / Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

Status: Closed to Accrual

Description

The study is designed as a Phase II, multicenter trial of vaccination with Dendritic cell / myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is hypothesized that the dendritic cell myeloma vaccine will result in improved response in patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).

Eligibility Criteria

Inclusion Criteria

  • Patients must be considered transplant eligible by the treating physician at time of study entry.
  • Patients must meet the criteria for symptomatic multiple myeloma prior to initiating systemic anti-myeloma treatment.
  • Age >18 years and ≤ 70 years at the time of enrollment
  • Karnofsky Performance status of ≥ 70%
  • Patients must have > 20% plasma cells in the bone marrow aspirate differential <60 days prior to enrollment. The required bone marrow evaluation will need to be repeated for patients who received more than 1 cycle of anti-myeloma therapy (corticosteroid with or without other anti-myeloma agents)
  • Patients must have received ≤ 1 cycles of systemic anti-myeloma therapy.
  • Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated.

Exclusion Criteria

  • Patients with a prior autologous or allogeneic HCT
  • Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
  • Patients with Plasma Cell Leukemia
  • Patients with disease progression prior to enrollment
  • Patients seropositive for the human immunodeficiency virus (HIV).
  • Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
  • Patients with active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible.
  • Patients receiving other investigational immunotherapy or anti-myeloma drugs within 14 days before enrollment.
  • Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is allowed.
  • Female patients who are pregnant (positive beta-HCG) or breastfeeding.
  • Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques (Appendix D) during the length of lenalidomide maintenance therapy.
  • Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.
  • Prior organ transplant requiring immunosuppressive therapy.
  • Patients who previously received lenalidomide and have experienced toxicities resulting in treatment discontinuation.
  • Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
  • Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
  • Patients unable or unwilling to provide informed consent.
  • Patients unable or unwilling to return to the transplant center for their assigned treatments.

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Ajay Kumar Nooka
Email: anooka@emory.edu

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Sunita Philip
Phone: 410-328-8199
Email: sphilip1@umm.edu
Rockville
Blood and Marrow Transplant Clinical Trials Network
Status: Approved
Contact: Mary M. Horowitz
Phone: 414-805-4380
Email: marymh@mcw.edu

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: David E. Avigan
Email: davigan@bidmc.harvard.edu
Brigham and Women's Hospital
Status: Active
Contact: Nikhil C. Munshi
Phone: 877-442-3324
Email: nikhil_munshi@dfci.harvard.edu
Dana-Farber Cancer Institute
Status: Active
Contact: David E. Avigan
Email: davigan@bidmc.harvard.edu

Nebraska

Omaha
University of Nebraska Medical Center
Status: Active
Contact: Matthew Alexander Lunning
Phone: 402-559-6941
Email: unmcrsa@unmc.edu

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Objectives and Outline

The study is a three-arm, phase II randomized, open-labeled clinical trial that randomizes patients to vaccination with Dendritic Cell (DC)/myeloma fusions/GM-CSF plus lenalidomide maintenance therapy or lenalidomide maintenance therapy with or without GM-CSF following autologous transplant as part of upfront treatment for patients diagnosed with multiple myeloma. Patients are randomized approximately 2 months post transplant and will begin maintenance lenalidomide between day 90 and 100. The primary objective of this randomized trial is to compare the proportion of patients alive and in complete response (defined as CR or sCR) at one year post transplant between patients receiving DC/myeloma vaccine/GM-CSF with lenalidomide maintenance therapy to those receiving lenalidomide maintenance therapy with or without GM-CSF.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
National Heart Lung and Blood Institute

Trial IDs

Primary ID BMTCTN1401
Secondary IDs NCI-2016-00911, U01HL069294, BMT CTN 1401
Clinicaltrials.gov ID NCT02728102