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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00615589
• Other study ID #: umcc 2007.074
• Secondary ID: HUM00014029
• Status: Terminated
• Phase: Phase 2
• First received: January 22, 2008
• Last updated: August 11, 2015
• Start date: February 2008
• Est. completion date: January 2013

Study information

• Verified date: August 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Leukemia, Plasma Cell
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Leukemia

Intervention

Drug:
• 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.

Procedure:
• stem cell transplant
Allogeneic, peripheral blood stem cell transplant

Locations

Country	Name	City	State
United States	University of Michigan,Department of Internal Med. Hematology- Oncology	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Patients Alive 1 Year Post Transplant	The primary objective is overall survival, one year from the time of transplant.	1 Year	Yes
Secondary	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.	1 Year	Yes
Secondary	Treatment-related Mortality		100 days, one-year	Yes
Secondary	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	100 days, 2 years	Yes
Secondary	Non Relapse Mortality		2 years	Yes