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

NCT00615589 | Terminated Phase 2 Results DMC

• 2 other identifiers: umcc 2007.074HUM00014029
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Stage II/III Multiple Myeloma(within 10 months from diagnosis); high risk; relapse; persistent

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients Alive 1 Year Post Transplant

  The primary objective is overall survival, one year from the time of transplant.

  1 Year

Secondary Outcomes (4)

• The Percentage of Patients Free From Progression at 1 Year

  1 Year

• Percentage of Patients With Treatment Related Mortality (TRM)

  100 days, one-year

• Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)

  100 days, 2 years

• Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression

  3 years

Study Arms (1)

Flu-Bu4

EXPERIMENTAL

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

Drug: Fludarabine/Busulfan x 4 days; Procedure: stem cell transplant

Interventions

Fludarabine/Busulfan x 4 days 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.

Flu-Bu4

stem cell transplant PROCEDURE

Allogeneic, peripheral blood stem cell transplant

Flu-Bu4

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (1)

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

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Plasma Cell; Recurrence

Interventions

fludarabine; Stem Cell Transplantation

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; Leukemia; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Attaphol Pawarode, M.D.
• Organization: University of Michigan Comprehensive Cancer Center

pawarode@umich.edu

734-936-8785

Study Officials

• Attaphol Pawarode, MD

  University of Michigan Dept. of Internal Medicine

  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: January 22, 2008
• First Posted: February 14, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 4, 2016
• Results First Posted: December 11, 2014

Record last verified: 2016-03

Locations

US (1)