Bortezomib With Melphalan and Prednisone for Multiple Myeloma

NCT00734149 | Completed Phase 2 Results

• 2 other identifiers: Pro000080896019
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of bortezomib in combination with melphalan and prednisone to achieve complete responses for patients with previously untreated multiple myeloma compared to an historical control group. This trial will also evaluate the safety and toxicity of this regimen as well as evaluate the duration of response of this regimen.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Response

  Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A \<50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a \<50% reduction in the urine M-component (Bence-Jones protein.

  6 weeks following completion of treatment

Secondary Outcomes (2)

• Number of Patients With Any Grade or Severe Adverse Event

  At any time during the study and up to 30 days after stopping the study drug

• Median Duration of Response

  up to 4 years

Study Arms (1)

Bortezomib+Melphalan+Prednisone

EXPERIMENTAL

Bortezomib 1.3 mg/m2 is administered intravenously in a 3-5 second bolus on days 1, 4, 8, and 11 of a 28 day cycle. Six cycles are planned. On days when both melphalan and bortezomib are given, melphalan is given at least one hour prior to bortezomib. Melphalan 6 mg/m2 is administered orally on an empty stomach daily on days 1-7 of each cycle. Prednisone 60 mg/m2 is administered orally daily on days 1-7 of each cycle.

Drug: Bortezomib; Drug: Melphalan; Drug: Prednisone

Interventions

Bortezomib DRUG

Also known as: Velcade

Bortezomib+Melphalan+Prednisone

Melphalan DRUG

Bortezomib+Melphalan+Prednisone

Prednisone DRUG

Bortezomib+Melphalan+Prednisone

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed multiple myeloma, defined as at least one of the following major criteria and one minor criterion or at least three minor criteria:
• Major Criteria Minor Criteria Plasmacytoma on tissue biopsy Marrow plasmacytosis 10-29% Marrow plasmacytosis ≥ 30% Monoclonal protein present, less than major criteria Monoclonal protein: Lytic bone lesions
• Immunoglobulin G (IgG) \> 3.5 g/dl Decrease in uninvolved immunoglobulins:
• Immunoglobulin A (IgA) \> 2 g/dl Immunoglobulin M (IgM) \< 50 mg/dl Bence Jones ≥ 1 g/24 hr IgA \< 100 mg/dl IgG \< 600 mg/dl
• No prior therapy
• Life expectancy greater than 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Karnofsky \>40%
• Patients must have normal organ and marrow function. Patients with severe pancytopenia due to myeloma involvement of the bone marrow and patients with renal insufficiency (creatinine \> 2 mg/dl) due to myeloma will also be included.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Pregnant women
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, melphalan, or other agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with bortezomib or other agents administered during the study.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Melphalan; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Cristina Gasparetto, MD
• Organization: Duke University Medical Center

gaspa001@mc.duke.edu

919-668-1017

Study Officials

• Cristina Gasparetto, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: August 14, 2008
• Study Start: July 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 7, 2023
• Results First Posted: May 31, 2013

Record last verified: 2016-03

Locations

US (1)