A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE

An Open-Labeled, Randomized Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE in Patients With Relapsed Multiple Myeloma Who Have Failed Four or More Lines of Therapy

The purpose of this study is to give patients who have had 4 or more prior lines of therapy for multiple myeloma access to VELCADE. The study is for patients who are not eligible for other clinical trials with VELCADE and for who VELCADE would otherwise not be available.

Study Overview

• Status: No longer available
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Bortezomib

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Michael Meshad, Oncology Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Ohio
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Major Criteria:

• Plasmacytomas on tissue biopsy
• Bone marrow plasmacytosis (> 30% plasma cells)
• Monoclonal IgG is > 3.5 g/dL or IgA is > 2.0 g/dL; kappa or lambda light chain excretion is > 1 g/day on a 24 hour urine sample.

Minor criteria:

• Bone marrow plasmacytosis (10 to 30%)
• Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria.
• Lytic bone lesions

Other Eligibility Requirements:

• Patient is not eligible for Millennium Study M34101-039.
• Patient has received 4 or more lines of therapy for multiple myeloma and, in the investigator's opinion, currently needs therapy because of relapsed or progressive disease.
• Patient is of legal consenting age, as defined by local regulations.
• Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
• Female patients must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control throughout the study.
• Male patients must agree to use an acceptable method of birth control throughout the study.
• Patient has a Karnofsky performance status of greater than or equal to 60%.
• Patient meets pretreatment laboratory criteria at and within 14 to 21 days before Baseline (Day 1 of Cycle 1, before study drug administration).

Exclusion Criteria:

• Patient progressed while receiving VELCADE previously in a clinical trial.
• Patient has been treated in Millennium Study M34101-039.
• Patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 1 week before enrollment in the study.
• Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment in the study.
• Patient received immunotherapy or antibody therapy within 4 weeks before enrollment.
• Patient had major surgery with 4 weeks before enrollment (kyphoplasty isn't considered major surgery).
• Patient has a history of allergic reactions due to compounds containing boron or mannitol.
• Patient has peripheral neuropathy of Grade 2 or greater, as defined by the National Cancer Institute Common Toxicity Criteria (NCI CTC).
• Patient has a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiogram shows evidence of acute ischemia or active conduction system abnormalities.
• Patient has cardiac amyloidosis
• Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment.
• Patient is known to be infected with human immunodeficiency virus (HIV positive).
• Patient is known to be hepatitis B positive or has active hepatitis C infection.
• Patient has an active systemic infection requiring treatment.
• Female patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant is required. Pregnancy testing is not required for post-menopausal or surgically sterilized patients.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: July 7, 2003
• First Submitted That Met QC Criteria: July 7, 2003
• First Posted (Estimate): July 8, 2003

Study Record Updates

• Last Update Posted (Estimate): February 14, 2007
• Last Update Submitted That Met QC Criteria: February 13, 2007
• Last Verified: July 1, 2003

More Information

Terms related to this study

• Keywords: Relapsed or Refractory
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Bortezomib
• Other Study ID Numbers: M34102-052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No