Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma

NCT01090921 | Completed Phase 2 Results DMC

• 1 other identifier: X05153
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

Brief Summary

This is a research study to see if a new drug called bortezomib is useful to treat multiple myeloma in people who are newly diagnosed, and have not yet received treatment for their disease. VELCADE® (bortezomib) for Injection is a drug under development by Millennium Pharmaceuticals, Inc.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Bortezomib; Newly diagnosed; Newly diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants at Each Response Category (Stable Disease, Minimal Response, Partial Response, Very Good Partial Response, Near Complete Response/Complete Resonse)

  To evaluate the response rate for weekly administered bortezomib + dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for transplant or who are eligible but wish to postpone autologous stem cell transplant.

  Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.

Secondary Outcomes (1)

• Number of Participants With Dose Reductions in Bortezomib, Dexamethasone or Both

  Data was collected for each subject for the duration of the participation in the study, which was an average of 4.8 cycles.

Study Arms (1)

Single-Arm

EXPERIMENTAL

Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.

Drug: Bortezomib

Interventions

Bortezomib DRUG

Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.

Also known as: Velcade

Single-Arm

Eligibility Criteria

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

You may qualify if:

• Diagnosis of multiple myeloma based on standard criteria.
• Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1Gm/dL and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours.
• Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
• Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
• Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
• Age\>65
• Impaired renal function (creatinine≥2.0 mg/dL)
• Impaired pulmonary function (DLCO≤50%)
• Poor performance status (KPS≤80)
• Other prohibitive comorbid disorder
• b. Patients≥60 who decline autologous stem cell transplant are eligible for this study.
• c. Patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study.
• Karnofsky performance status\>50
• Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period Spot RT to ≤3 vertebrae acceptable prior to entry.
• Meets the following pretreatment laboratory criteria at Baseline (Within 14 days prior to study drug administration):

You may not qualify if:

• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
• Plasma cell leukemia
• Impaired kidney function requiring dialysis, patients on hemodialysis are excluded
• Receiving steroids \>the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
• Infection not controlled by antibiotics
• HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice
• Known active hepatitis B or C
• Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Second malignancy requiring concurrent treatment
• Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
• Positive pregnancy test in women of childbearing potential
• Patient has hypersensitivity to boron or mannitol.
• Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
• Patient has received other investigational drugs with 14 days before enrollment

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (11)

Little Rock VA Medical Center

Little Rock, Arkansas, 72205, United States

Location

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

West Haven VA Medical Center

West Haven, Connecticut, 06516, United States

Location

Tampa VA Medical Center

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

VA Boston Healthcare System

Jamaica Plain, Massachusetts, 02130, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Pittsburgh VA Medical Center

Pittsburgh, Pennsylvania, 15240, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Girnius SK, Lee S, Kambhampati S, Rose MG, Mohiuddin A, Houranieh A, Zimelman A, Grady T, Mehta P, Behler C, Hayes TG, Efebera YA, Prabhala RH, Han A, Yellapragada SV, Klein CE, Roodman GD, Lichtenstein A, Munshi NC. A Phase II trial of weekly bortezomib and dexamethasone in veterans with newly diagnosed multiple myeloma not eligible for or who deferred autologous stem cell transplantation. Br J Haematol. 2015 Apr;169(1):36-43. doi: 10.1111/bjh.13243. Epub 2015 Jan 8.

  PMID: 25572917 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

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

Results Point of Contact

• Title: Nikhil C. Munshi, M.D.
• Organization: BVARI

nikhil_munshi@dfci.harvard.edu

857-203-6172

Study Officials

• Nikhil C. Munshi, M.D.

  Boston VA Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

• Saem Lee

  Boston VA Research Institute, Inc.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesetigator -- Coordinating Site

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 23, 2010
• Study Start: May 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 9, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)