search
Back to results

Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of intermediate or advanced multiple myeloma meeting criteria for at least 1 2 following: Intermediate- to high-M-component production rates (immunoglobulin [Ig]G > 5 g/dL or immunoglobulin A (IgA) > 3 g/dL or urine M component > 4 g/24 hours) More than one osteolytic bone lesion or radiographic evidence of diffuse osteoporosis β-2 microglobulin > 3 Nonsecretory myeloma if bone marrow plasmacytosis is greater than 30% Must have undergone autologous peripheral blood stem cell transplantation within the past 3-4 months Age 18 to 69 years old Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 30,000/mm^3 serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 300 IU Bilirubin ≤ 2 mg/dL Creatinine ≤ 2.0 mg/dL Creatinine clearance ≥ 30 mL/min Negative pregnancy test Fertile patients must use effective contraception Exclusion Criteria: concurrent major cardiac disease that would preclude study participation concurrent major pulmonary disease that would preclude study participation pregnant or nursing peripheral neuropathy ≥ grade 2 history of hypersensitivity to bortezomib, boron, or mannitol concurrent major gastrointestinal or bladder disease that would preclude study participation concurrent major neurologic or psychiatric disease that would preclude study participation dementia or significantly altered mental status that would preclude giving informed consent prior interferon post-transplantation prior thalidomide post-transplantation prior chemotherapy post-transplantation prior radiotherapy post-transplantation prior investigational therapy post-transplantation prior bortezomib prior therapy for myeloma post-transplantation other concurrent anti-myeloma therapy other concurrent investigational therapy

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bortezomib

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival
Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
June 10, 2004
Last Updated
August 3, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00084747
Brief Title
Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
Official Title
Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving bortezomib as maintenance therapy after autologous stem cell transplantation may kill more cancer cells and prolong remission. PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant bortezomib as maintenance therapy and to see how well it works in treating patients who have undergone stem cell transplantation for intermediate or advanced multiple myeloma.
Detailed Description
OBJECTIVES: Determine response rate, as defined by resolution of bone marrow plasmacytosis and monoclonal paraproteinemia, in the first year after autologous peripheral blood stem cell transplantation in patients with intermediate or advanced multiple myeloma treated with adjuvant bortezomib. Compare progression-free survival of patients treated with adjuvant bortezomib with historical controls treated with autologous transplantation alone. Determine the toxicity of this drug in these patients (phase I). OUTLINE: This is a multicenter, dose-escalation study. Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bortezomib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bortezomib
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.
Time Frame
signed consent to progression or end of trial. Up to 5 years.
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
up to 5 years from time of consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of intermediate or advanced multiple myeloma meeting criteria for at least 1 2 following: Intermediate- to high-M-component production rates (immunoglobulin [Ig]G > 5 g/dL or immunoglobulin A (IgA) > 3 g/dL or urine M component > 4 g/24 hours) More than one osteolytic bone lesion or radiographic evidence of diffuse osteoporosis β-2 microglobulin > 3 Nonsecretory myeloma if bone marrow plasmacytosis is greater than 30% Must have undergone autologous peripheral blood stem cell transplantation within the past 3-4 months Age 18 to 69 years old Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 30,000/mm^3 serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 300 IU Bilirubin ≤ 2 mg/dL Creatinine ≤ 2.0 mg/dL Creatinine clearance ≥ 30 mL/min Negative pregnancy test Fertile patients must use effective contraception Exclusion Criteria: concurrent major cardiac disease that would preclude study participation concurrent major pulmonary disease that would preclude study participation pregnant or nursing peripheral neuropathy ≥ grade 2 history of hypersensitivity to bortezomib, boron, or mannitol concurrent major gastrointestinal or bladder disease that would preclude study participation concurrent major neurologic or psychiatric disease that would preclude study participation dementia or significantly altered mental status that would preclude giving informed consent prior interferon post-transplantation prior thalidomide post-transplantation prior chemotherapy post-transplantation prior radiotherapy post-transplantation prior investigational therapy post-transplantation prior bortezomib prior therapy for myeloma post-transplantation other concurrent anti-myeloma therapy other concurrent investigational therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary J. Schiller, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Schiller GJ, Sohn JP, Malone P, et al.: Phase I/II trial of bortezomib maintenance following autologous peripheral blood progenitor cell transplantation as treatment for intermediate- and advanced-stage multiple myeloma. [Abstract] Biol Blood Marrow Transplant 13 (2 Suppl 1): A-153, 57, 2007.
Results Reference
result

Learn more about this trial

Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma

We'll reach out to this number within 24 hrs