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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: GVAX; Procedure: Autologous transplant

• Registration Number: NCT00024466
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-12
• Study Completion: 2009-04
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine	GVAX	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.
Vaccine	Autologous transplant	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States