Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma

NCT00616720 | Completed Phase 2

• 4 other identifiers: CDR0000582566P30CA015083998003789-99
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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 blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells. PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Confirmed response (i.e., clinical or immunological)

Interventions

aldesleukin BIOLOGICAL

idiotype-pulsed autologous dendritic cell vaccine APC8020 BIOLOGICAL

recombinant interferon gamma BIOLOGICAL

polymerase chain reaction GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

flow cytometry OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

aldesleukin; Interferon-gamma; Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Martha Q. Lacy, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 15, 2008
• Study Start: August 1, 2001
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 16, 2011

Record last verified: 2011-05