Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission
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.
Biological: Allogeneic Myeloma Vaccine
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction With a Lenalidomide Containing Regimen in Myeloma Patients With Near Complete Remission|
- The primary endpoint of this study is to show that we are able to improve the clinical response of these patients by converting them from immunofixation positive to negative. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Evaluate side effects of the myeloma vaccine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Effect on clonogenic myeloma precursors
- Evaluate toxicity of the myeloma vaccine
- Measure tumor specific immunity and correlate with systemic immunity
- Examine immune response to CRM-197 and correlate with myeloma immunity
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Experimental: Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide||
Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
Other Name: RevlimidBiological: Allogeneic Myeloma Vaccine
A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
Other Name: Granulocyte-macrophage colony stimulating factor, rHu GM-CSF, Leukine, SargramostimBiological: Prevnar-13
Prevnar-13 will be administered at 0.5ml dose by intramuscular injection.
Other Name: Pneumococcal 13-Valent Conjugate Vaccine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349569
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Ivan Borrello, M.D.||Johns Hopkins University|