Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation

NCT00002787 | Completed Phase 1

• 2 other identifiers: 1104.00NCI-2012-00669
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria

  Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.

  Up to 2 years

• Immune response

  Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.

  Up to 2 years

Study Arms (1)

Treatment (vaccine therapy)

EXPERIMENTAL

Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.

Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine; Biological: sargramostim; Biological: aldesleukin; Other: laboratory biomarker analysis

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine BIOLOGICAL

Given SC

Also known as: autologous immunoglobulin idiotype-keyhole limpet hemocyanin conjugate vaccine, GTOP-99, Id-KLH, Id-KLH conjugate vaccine, recombinant Id-KLH

Treatment (vaccine therapy)

sargramostim BIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine

Treatment (vaccine therapy)

aldesleukin BIOLOGICAL

Given SC

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

Treatment (vaccine therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (vaccine therapy)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ELIGIBILITY FOR VACCINE PREPARATION:
• Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation
• Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible
• ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION:
• Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera
• Greater than 60 days post BMT
• Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse
• Stable absolute neutrophil count (ANC) \> 1000
• Platelet count \> 50,000 not requiring transfusions or growth factors
• Red blood cell (RBC) supportable to hematocrit (Hct) \> 25 with less than 2 units of packed red blood cell (PRBC)/week
• Treatment with a stable dose of Interferon is allowed
• Karnofsky status \> 60 percent
• Immunosuppression:
• Off all corticosteroids
• Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only

You may not qualify if:

• Graft-vs-host disease requiring treatment with corticosteroids
• Serum creatinine \> 3.0
• Uncontrolled infection
• Disease progression
• Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol
• Patients with a history of serious adverse reactions to GM-CSF
• Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF

Sponsors & Collaborators

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; aldesleukin; Interleukin-2

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interleukins; Lymphokines

Study Officials

• David Maloney

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 21, 2004
• Study Start: March 1, 1996
• Primary Completion: December 1, 2002
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)