Clinical trial NCT00615589: Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Official title: Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Plasma Cell Leukemia
Keywords: Stage II/III Multiple Myeloma(within 10 months from diagnosis)
high risk
relapse
persistent
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Development & Commercialization, Inc.
First posted: 2008-02-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Percentage of Patients Alive 1 Year Post Transplant
timeFrame: 1 Year
Secondary outcomes:
measure: The Percentage of Patients Free From Progression at 1 Year
timeFrame: 1 Year
measure: Percentage of Patients With Treatment Related Mortality (TRM)
timeFrame: 100 days, one-year
measure: Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
timeFrame: 100 days, 2 years
measure: Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
timeFrame: 3 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan,Department of Internal Med. Hematology- Oncology
state: Michigan
Study officials:
affiliation: University of Michigan Dept. of Internal Medicine
name: Attaphol Pawarode, MD
role: PRINCIPAL_INVESTIGATOR
References: