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Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction With a Lenalidomide Containing Regimen in Myeloma Patients With Near Complete Remission

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Administration of an Allogeneic Myeloma GM-CSF Vaccine in Conjunction With a Lenalidomide Containing Regimen in Myeloma Patients With Near Complete Remission

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ivan Borrello, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

June 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410