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Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Multiple Myeloma, Plasma Cell Leukemia

Thank you

Trial Information

Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival, one year from the time of transplant

Outcome Time Frame:

one-year

Safety Issue:

Yes

Principal Investigator

Attaphol Pawarode, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Dept. of Internal Medicine

Authority:

United States: Institutional Review Board

Study ID:

umcc 2007.074

NCT ID:

NCT00615589

Start Date:

February 2008

Completion Date:

September 2015

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Leukemia
  • Stage II/III Multiple Myeloma(within 10 months from diagnosis)
  • high risk
  • relapse
  • persistent
  • Leukemia
  • Leukemia, Plasma Cell
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Michigan,Department of Internal Med. Hematology- OncologyAnn Arbor, Michigan  48109