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Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission

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ClinicalTrials.gov Identifier: NCT01349569
Recruitment Status : Completed
First Posted : May 6, 2011
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE May 5, 2011
First Posted Date  ICMJE May 6, 2011
Results First Submitted Date  ICMJE November 29, 2018
Results First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Time to Response [ Time Frame: Up to 4 years ]
    Median time for conversion of response 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. as measured by immunofixation converting from positive to negative.
  • Effect on Clonogenic Myeloma Precursors [ Time Frame: Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year ]
    Measures of stem cell population and plasma cell population.
  • Grade 3-4 Toxicity [ Time Frame: Up to 1 year ]
    Number of participants who experienced grade 3-4 toxicity as per CTCAE 4.0.
  • Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells [ Time Frame: Baseline, Cycle 3 Day 14, end of study (up to 1 year) ]
    Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
Evaluate side effects of the myeloma vaccine [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission
Official Title  ICMJE Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction With a Lenalidomide Containing Regimen in Myeloma Patients With Near Complete Remission
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: 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: Revlimid
  • Biological: 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.
  • Biological: Prevnar-13
    Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
    Other Name: Pneumococcal 13-Valent Conjugate Vaccine
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Drug: Lenalidomide
  • Biological: Allogeneic Myeloma Vaccine
  • Biological: Prevnar-13
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2011)
15
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01349569
Other Study ID Numbers  ICMJE J1115
NA_00044463 ( Other Identifier: JHMIRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Responsible Party Ivan Borrello, M.D., Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Current Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Ivan Borrello, M.D. Johns Hopkins University
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP