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

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ClinicalTrials.gov Identifier: NCT00084747
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : March 15, 2016
Last Update Posted : August 17, 2020
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: bortezomib Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arms and Interventions
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Arm Intervention/treatment
Experimental: bortezomib Drug: bortezomib


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: signed consent to progression or end of trial. Up to 5 years. ]
    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 :
  1. Overall Survival [ Time Frame: up to 5 years from time of consent ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084747


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

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00084747    
Other Study ID Numbers: CDR0000365583
UCLA-0306106
MILLENNIUM-MM2003
First Posted: June 11, 2004    Key Record Dates
Results First Posted: March 15, 2016
Last Update Posted: August 17, 2020
Last Verified: February 2016
Keywords provided by Jonsson Comprehensive Cancer Center:
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents