Clinical trial NCT00024466: Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Official title: Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor-specific immune response
timeFrame: Up to 1 year
Secondary outcomes:
measure: Grade 3-4 toxicity
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Ivan Borrello, MD
role: STUDY_CHAIR
References: