Protocol SummaryBack To Search Instructions
Protocol No.1611GCCPrincipal InvestigatorRapoport, Aaron
PhasePhase II
Age GroupAdult
TitlePhase II Multicenter Trial of Single Autologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell/Myeloma Fusion
DescriptionThis is a Phase II multicenter trial of vaccination with DC/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).
TreatmentAutologous Hematopoietic Cell Transplant Followed by Lenalidomide Maintenance for Multiple Myeloma with or without Vaccination with Dendritic Cell/Myeloma Fusions.
Key EligibilityInclusion
1. Transplant Eligible
2. Meet criteria for symptomatic multiple myeloma
3. Age 18 – 71
4. 20% plasma cells in the bone marrow < 60 days prior to enrollment as per the protocol.


Inclusion for Randomization:
1. Patients received transplant less than or equal to 12 months from enrollment onto BMT CTN 1401
2. No disease progression since initiation of systemic anti-myeloma therapy
3. Received autologous transplant with melphalan 200mg/m2 with a minimum cell dose of 2x106 CD34+ cells/kg
4. No evidence of uncontrolled infection requiring systemic therapy
5. Patients must be willing to receive DVT prophylaxis
6. Patient must be willing to follow birth control practices outlined in the protocol

Exclusion:
1. Prior Autologous or Allogeneic HCT
2. Non secretory multiple myeloma (defined as normal serum and urine immunofixation and normal serum free light chain assay).
3. Patients with Plasma Cell Leukemia
4. Patients with prior disease progression
5. Patients seropositive for the human immunodeficiency virus (HIV).
6. Patients with active clinically significant autoimmune disease as defined by the protocol.
7. Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.
Applicable Disease SitesMultiple Myeloma
Therapies InvolvedBone Marrow Transplant
Chemotherapy (NOS)
Immunotherapy
Vaccine
Drugs InvolvedGM-CSF
LENALIDOMIDE
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02728102
ContactGreenebaum Comprehensive Cancer Center: Sunita Philip, MS, CCRP Phone:410-328-8199
Pager:
Email:sphilip1@umm.edu
Back to Protocol Listing