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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GVAX
Autologous transplant
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Grade 3-4 toxicity
Percentage of participants with grade 3-4 toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE 2.0).

Full Information

First Posted
September 13, 2001
Last Updated
September 17, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00024466
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2001 (Actual)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
GVAX
Other Intervention Name(s)
Autologous tumor vaccine
Intervention Type
Procedure
Intervention Name(s)
Autologous transplant
Other Intervention Name(s)
Auto BMT, Auto SCT
Primary Outcome Measure Information:
Title
Tumor-specific immune response
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Grade 3-4 toxicity
Description
Percentage of participants with grade 3-4 toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE 2.0).
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Borrello, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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