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

September 17, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: GVAX
Other Names:
  • Autologous tumor vaccine
Procedure: Autologous transplant
Other Names:
  • Auto BMT
  • Auto SCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-specific immune response
Time Frame: 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.
Up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ivan Borrello, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2001

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0115
  • P30CA006973 (U.S. NIH Grant/Contract)
  • 01-01-17-06 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on GVAX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe