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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01349569
First received: May 5, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide
Biological: Allogeneic Myeloma Vaccine
Biological: Prevnar-13
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 15
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)
Arms Assigned Interventions
Experimental: Myeloma Vaccine, Prevnar-13 Vaccine, & Lenalidomide 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.
Other Name: Granulocyte-macrophage colony stimulating factor, rHu GM-CSF, Leukine, Sargramostim
Biological: Prevnar-13
Prevnar-13 will be administered at 0.5ml dose by intramuscular injection.
Other Name: Pneumococcal 13-Valent Conjugate Vaccine

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349569

Contacts
Contact: Ivan Borrello, M.D. 410-955-4967 iborrell@jhmi.edu
Contact: Anna Ferguson, BSN 410-614-4838 afergus1@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Ivan Borrello, M.D.    410-955-4967    iborrell@jhmi.edu   
Principal Investigator: Ivan Borrello, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Ivan Borrello, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01349569     History of Changes
Other Study ID Numbers: J1115, NA_00044463
Study First Received: May 5, 2011
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014