Bortezomib (Velcade) Post Allogenic Peripheral Blood Stem Cell Transplantation for Myeloma

NCT00504634 | Completed Phase 2

• 1 other identifier: 2003-0751
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: 1\. To determine the antimyeloma effect of bortezomib after allogeneic transplantation for patients with multiple myeloma. Secondary Objective 1\. To determine the toxicity profile of bortezomib in patients with multiple myeloma undergoing allogeneic progenitor cell transplantation.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Post Allogeneic Transplantation; Bortezomib; Velcade; PS-341

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Complete Response (CR)

  Response rate (CR), evaluated within 6 weeks of beginning treatment, assessed using The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry (EBMT/IBMTR) response criteria of Complete Response (CR), Minimal Response (MR), No Change (NC), or Progressive Disease (PD).

  6 weeks from beginning treatment

Study Arms (1)

Bortezomib

EXPERIMENTAL

1 mg/m\^2 intravenous (IV) Days 1, 4, 8, and 11.

Drug: Bortezomib

Interventions

Bortezomib DRUG

1 mg/m\^2 IV On Days 1, 4, 8, and 11.

Also known as: Velcade, PS-341

Bortezomib

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma at least 3 months post allogeneic transplant who either failed to achieve a complete remission or are relapsing.
• Allograft performed from a related donor who is HLA-compatible (5/6 or 6/6), or class I serologic match and class II molecular matched unrelated donor).
• Zubrod Points Scale (PS) \< 2, life expectancy is not severely limited by concomitant illness.
• Patient willing and able to sign informed consent.
• Patients less than 70 years of age.

You may not qualify if:

• Active Central Nervous System (CNS) disease.
• Uncontrolled acute or chronic Graft-versus-host disease (GVHD).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

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

Study Officials

• Sergio A. Giralt, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 20, 2007
• Study Start: January 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: May 1, 2010
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

US (1)