Trials Sponsors Conditions Drugs Pricing

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

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

Interventions

aldesleukinBiological

idiotype-pulsed autologous dendritic cell vaccine APC8020Biological

recombinant interferon gammaBiological

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Mayo Clinic
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

aldesleukinInterferon-gammaPolymerase Chain ReactionReverse Transcriptase Polymerase Chain ReactionFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein Disorders

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 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2007

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record