Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

NCT ID: NCT00615589

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-01-31

Brief Summary

Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.

This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.

Conditions

Multiple Myeloma; Plasma Cell Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flu-Bu4

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Group Type: EXPERIMENTAL

Fludarabine/Busulfan x 4 days

Intervention Type: DRUG

• Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.
• Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.

The Fludarabine shall be administered prior to the Busulfan each day.

stem cell transplant

Intervention Type: PROCEDURE

Allogeneic, peripheral blood stem cell transplant

Interventions

Fludarabine/Busulfan x 4 days

• Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.
• Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.

The Fludarabine shall be administered prior to the Busulfan each day.

Intervention Type: DRUG

stem cell transplant

Allogeneic, peripheral blood stem cell transplant

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Biologic high risk Multiple Myeloma:

• Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics.

• Relapsed or persistent multiple myeloma after ASCT.
• Persistent multiple myeloma, regardless of previous therapies.
• Plasma cell leukemia, regardless of previous therapies.
• Age up to 70 years old (less than 71 years old at the date of transplant admission).
• Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
• Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
• Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)

Exclusion Criteria

• Persistent invasive infections, not controlled by antimicrobials.
• HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity.
• Uncontrolled medical or psychiatric disorder.
• No response or progressive disease at the time of transplantation.
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Attaphol Pawarode, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Dept. of Internal Medicine

Locations

University of Michigan,Department of Internal Med. Hematology- Oncology

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00014029

Identifier Type: -

Identifier Source: secondary_id

umcc 2007.074

Identifier Type: -

Identifier Source: org_study_id