NCT00024466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

3.7 years

First QC Date

September 13, 2001

Last Update Submit

September 17, 2018

Conditions

Multiple Myeloma

Keywords

stage I multiple myelomastage II multiple myelomastage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Tumor-specific immune response

    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 Outcomes (1)

  • Grade 3-4 toxicity

    Up to 1 year

Study Arms (1)

Vaccine

EXPERIMENTAL

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: GVAXProcedure: Autologous transplant

Interventions

GVAXBIOLOGICAL
Also known as: Autologous tumor vaccine
Vaccine
Autologous transplantPROCEDURE
Also known as: Auto BMT, Auto SCT
Vaccine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +18 more criteria

You may not qualify if:

  • Failure of autologous tumor-cell processing for vaccine production

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

FANG vaccineTransplantation, Autologous

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Ivan Borrello, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

April 1, 2001

Primary Completion

December 1, 2004

Study Completion

April 1, 2009

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)