Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation
Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
NCT00002787CI-TRIAL-00038464completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage III Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage II Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Stage I Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous immunoglobulin idiotype-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vaccine therapy)
- description
- 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.
- interventionNames
- Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
- Biological: sargramostim
- Biological: aldesleukin
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
- timeFrame
- Up to 2 years
- description
- Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.