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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00084747
First received: June 10, 2004
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: bortezomib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression-free and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease progression rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2004
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bortezomib Drug: bortezomib

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  • SGOT or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084747

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Gary J. Schiller, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00084747     History of Changes
Other Study ID Numbers: CDR0000365583, P30CA016042, UCLA-0306106, MILLENNIUM-MM2003
Study First Received: June 10, 2004
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014