Status:
COMPLETED
Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blo...
Detailed Description
OBJECTIVES: Primary * To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:
- Serum and urine monoclonal (M) protein values must be stable (\< 20% variation) or must have disappeared
- Serum M protein \< 1 g/dL, and 1 of the following:
- Quantifiable serum M protein
- Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
- Urine M protein \< 200 mg/24 hours by electrophoresis on 2 separate occasions for a period of ≥ 4 weeks
- Serum M protein spike ≤ 2.0 g/dL
- No progressive disease after prior autologous stem cell transplantation or chemotherapy
- No non-secretory or light chain myeloma
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- WBC ≥ 1,500/μL
- Platelet count ≥ 50,000/μL
- Total bilirubin ≤ 5 times upper limit of normal
- Creatinine ≤ 5.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have adequate venous access for apheresis
- No uncontrolled cardiac disease
- No uncontrolled infection
- No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints
- PRIOR CONCURRENT THERAPY:
- Recovered from all prior therapy
- More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
- More than 3 months since prior high-dose chemotherapy with stem cell transplantation
- No concurrent corticosteroids
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00616720
Start Date
August 1 2001
End Date
November 1 2007
Last Update
May 16 2011
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