Clinical trial · Interventional
Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous transplant | Procedure | — | UNRESOLVED |
| GVAX | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine
- description
- Participants are vaccinated with GVAX one month or more after finishing induction therapy (which is given as per standard of care). Two weeks later, participants go through leukapheresis on protocol, then receive autologous transplant as per standard of care. GVAX is administered eight subsequent times after the autologous transplant.
- interventionNames
- Biological: GVAX
- Procedure: Autologous transplant
Primary outcomes (1)
- measure
- Tumor-specific immune response
- timeFrame
- Up to 1 year
- description
- Percentage of participants who had a delayed-type hypersensitivity reaction with induration greater than or equal to 5 millimeters to an intradermal injection of irradiated autologous tumor cells.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
INCLUSION CRITERIA Initial Presentation * Age between 18 and 70 years * ECOG 0 - 2 * Patients with histologically confirmed multiple myeloma with ≥ 30% bone * marrow involvement and a de novo presentation. One cycle of prior * chemotherapy for myeloma is allowed. Local radiation therapy is permitted * Ability to give informed consent * No existing secondary malignancies and no history of secondary malignancies in the past 5 years (other than a history of carcinoma in situ of the cervix, superficial skin cancer, or superficial bladder cancer) * No active autoimmune disease, nor a history of any autoimmune disease requiring medical treatment with systemic immunosuppressants * No corticosteroids within 28 days of tumor harvest * No major active medical or psychosocial problems that could be exacerbated or complicated by this treatment * Not pregnant * HIV negative * AST/ALT, total bilirubin \< threefold normal * Absolute neutrophil count \>500/mm3 * Platelet count \>30,000/mm3 Prior to Transplantation * ECOG performance status of 0 - 2. * No active/uncontrolled infection. * Absolute neutrophil count (ANC) \>1000/mm3. * Platelet count \>50,000/mm3. * Hemoglobin \>8g/dL * AST/ALT, total bilirubin \<3-fold normal. * 50% or greater reduction in tumor burden with prior chemotherapy * Patient has received a minimum of 2 cycles of an accepted induction * chemotherapy regimen * Patient fulfills the requirements for standard peripheral stem cell transplantation Prior to Posttransplant Vaccination * No active/uncontrolled infection * Absolute neutrophil count (ANC) \>1000/mm3 * Platelet count \>50,000/mm3 * Hemoglobin \>8g/dL * AST/ALT, total bilirubin \<3-fold normal * No unresolved Grade 3 or 4 adverse events related to the transplant EXCLUSION CRITERIA • Failure of autologous tumor-cell processing for vaccine production
References
Publications (0)
Data not yet available