Completed

Phase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma

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What is being tested

bortezomib

Drug
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

From 18 to 69 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitlePhase I/II Trial of Autologous Peripheral Blood Progenitor Cell Transplantation With VELCADE Maintenance as Treatment for Intermediate- and Advanced-Stage Multiple Myeloma 
NCT00084747
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 69 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPlasmacytomaVascular DiseasesHemostatic DisordersNeoplasms, Plasma Cell

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, United StatesSee the location
CompletedOne Study Center