Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction With a Lenalidomide Containing Regimen in Myeloma Patients With Near Complete Remission
Overview
- Phase
- Phase 2
- Intervention
- Lenalidomide
- Conditions
- Multiple Myeloma
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Response Conversion Rate
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This research is being done to find out if the investigators can improve outcomes for multiple myeloma patients by giving a myeloma vaccine to patients who are already on lenalidomide (Revlimid) and in a near complete remission.
Detailed Description
This is a single institution, single arm, Phase II study examining the clinical efficacy of an allogeneic GM-CSF secreting myeloma vaccine in combination with lenalidomide. Fifteen (15) patients enrolled in the study must have two disease measurements (including the last one) consistent with a near complete remission (M-spike negative with persistence of immunofixation) per criteria for response in a 6 month period. Patients will continue on the dose of lenalidomide they were on prior to being enrolled but will need to discontinue steroids for at least 4 weeks. Patients will receive 4 vaccinations on day 14(+/-3 days) of cycles 1, 2, 3 and 6 from enrollment that will include both the myeloma vaccine as well as Prevnar.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Myeloma eligibility criteria are the following:
- •sustained near complete remission (nCR) for 4 months defined as no measurable M-spike and a positive immunofixation
- •early biochemical relapse as manifest by going from a true CR (immunofixation negative) to a nCR (immunofixation positive) at any time
- •conversion from a nCR to the appearance of a monoclonal spike in the serum not greater than 0.3mg/dL
- •age 18 years and older
- •Eastern Cooperative Oncology Group performance scores 0-2
- •History of measurable serum or urine M protein or free light chains
- •Life expectancy greater than 12 months
- •Corrected serum calcium \< 11 mg/dL, and no evidence of symptomatic hypercalcemia
- •Serum creatinine\< 2
Exclusion Criteria
- •Disease progression after stopping corticosteroids as defined as the appearance of an M-spike \>0.5g/dL
- •Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory myeloma and amyloidosis.
- •HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study.
- •Patients who have participated in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug.
- •History of an active malignancy other than myeloma
- •Autoimmune disease requiring active treatment.
- •Known contra-indication to any component of Prevnar 13 including the diphtheria toxoid-containing vaccine.
- •History of latex allergy
- •History of an autologous stem cell transplant within the past 12 months or less
- •History of an allogeneic transplant
Arms & Interventions
Myeloma Vaccine, Prevnar, & Lenalidomide
Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study.
Intervention: Lenalidomide
Myeloma Vaccine, Prevnar, & Lenalidomide
Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study.
Intervention: Allogeneic Myeloma Vaccine
Myeloma Vaccine, Prevnar, & Lenalidomide
Lenalidomide will be continued on the same dose as was being administered prior to the study. The allogeneic myeloma vaccine and Prevnar-13 vaccine will be given on four days over the course of the study.
Intervention: Prevnar-13
Outcomes
Primary Outcomes
Response Conversion Rate
Time Frame: Up to 1 year
Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, \< 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.
Secondary Outcomes
- Effect on Clonogenic Myeloma Precursors(Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year)
- Time to Response(Up to 4 years)
- Grade 3-4 Toxicity(Up to 1 year)
- Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells(Baseline, Cycle 3 Day 14, end of study (up to 1 year))