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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00024466

Enrollment

Registered

2003-01-27

Start date

2001-04-30

Completion date

2009-04-30

Last updated

2018-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Brief summary

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.

Detailed description

OBJECTIVES: * Determine the efficacy of induction chemotherapy followed by autologous tumor cell vaccine and autologous peripheral blood stem cell transplantation in patients with multiple myeloma. * Determine the safety of this regimen in these patients. OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once. Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks after transplantation, patients receive additional ATCVs every 3 weeks for a total of 8 vaccinations. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Interventions

BIOLOGICALGVAX

PROCEDUREAutologous transplant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tumor-specific immune response	Up to 1 year	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

Measure	Time frame	Description
Grade 3-4 toxicity	Up to 1 year	Percentage of participants with grade 3-4 toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE 2.0).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026