Clinical trial NCT01349569: Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission
Official title: Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction With a Lenalidomide Containing Regimen in Myeloma Patients With Near Complete Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-05-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Absolute Neutrophil Count \>1000
* Platelet \>100,000
* Total bilirubin less than or equal to 1.5 x Upper limit of normal
* Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper limit of normal
* Negative pregnancy test if applicable
* Ability to comprehend and have signed the informed consent.
* Disease free of prior malignancies for \< 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
* Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
* Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin).

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

Primary outcomes:
measure: Response Conversion Rate
timeFrame: Up to 1 year
Secondary outcomes:
measure: Time to Response
timeFrame: Up to 4 years
measure: Effect on Clonogenic Myeloma Precursors
timeFrame: Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year
measure: Grade 3-4 Toxicity
timeFrame: Up to 1 year
measure: Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells
timeFrame: Baseline, Cycle 3 Day 14, end of study (up to 1 year)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ivan Borrello, M.D.
role: PRINCIPAL_INVESTIGATOR
References: