Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

NCT ID: NCT00024466

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2009-04-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaccine

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.

Group Type: EXPERIMENTAL

GVAX

Intervention Type: BIOLOGICAL

Autologous transplant

Intervention Type: PROCEDURE

Interventions

GVAX

Intervention Type: BIOLOGICAL

Autologous transplant

Intervention Type: PROCEDURE

Other Intervention Names

Autologous tumor vaccine; Auto BMT; Auto SCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Borrello, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

01-01-17-06

Identifier Type: OTHER

Identifier Source: secondary_id

J0115

Identifier Type: -

Identifier Source: org_study_id