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

NCT00084747 | Completed Phase 1 Results DMC

• 3 other identifiers: CDR0000365583UCLA-0306106MILLENNIUM-MM2003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  signed consent to progression or end of trial. Up to 5 years.

Secondary Outcomes (1)

• Overall Survival

  up to 5 years from time of consent

Study Arms (1)

bortezomib

EXPERIMENTAL

Drug: bortezomib

Interventions

bortezomib DRUG

bortezomib

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Gary Schiller
• Organization: UCLA

gschiller@mednet.ucla.edu

310-206-5755

Study Officials

• Gary J. Schiller, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 10, 2004
• First Posted: June 11, 2004
• Study Start: June 1, 2004
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 17, 2020
• Results First Posted: March 15, 2016

Record last verified: 2016-02

Locations

US (1)