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

Phase 2TerminatedNCT00615589

University of Michigan Rogel Cancer Center22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Plasma Cell Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Percentage of Patients Alive 1 Year Post Transplant

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

Time frame: 1 Year

Secondary Outcomes

The Percentage of Patients Free From Progression at 1 Year

One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.

Time frame: 1 Year

Percentage of Patients With Treatment Related Mortality (TRM)

Time frame: 100 days, one-year

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

Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus

Time frame: 100 days, 2 years

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

Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.

Time frame: 3 years