Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Multiple Myeloma Clinical Trial

Official title:

Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809276
• Other study ID #: J0844
• Secondary ID: NA_00017193
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 16, 2008
• Last updated: January 29, 2015
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Description:

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)

However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

• Patients ages between 0 to and 65 years of age.

• Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.

• Acute lymphocytic leukemia (ALL) in CR1 with high risk features

• Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]

• Acute Leukemias in 2nd or greater remission

• Refractory or Relapsed AML

• AML transformed from MDS

• Myelodysplastic syndrome (MDS) beyond refractory anemia

• Chronic myeloid leukemia (CML)

• Chronic myelomonocytic leukemia

• Philadelphia-negative myeloproliferative disorder

• Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma

• Multiple Myeloma-Stage III

Exclusion Criteria:

• Prior autologous or allogeneic stem cell transplant.

• Performance status greater than 2

• Active infection.

• Inadequate cardiac function; arrythmias or symptomatic cardiac disease.

• Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted

• Inadequate Serum creatinine clearance <60

• InadequatebHepatic function

• Positive serology for HIV-1, 2 or HTLV-1, 2.

• Pregnancy. Female patient must have negative pregnancy test

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• Busulfan, Fludarabine, Cytoxan
Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses

Locations

Country	Name	City	State
United States	The Sydney Kimmel Comprehensive Cancer center	Baltimore	Maryland
United States	Marcos deLima, MD	Houston	Texas
United States	Paul V. O'Donnell, M.D., Ph.D.	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	Fred Hutchinson Cancer Research Center, M.D. Anderson Cancer Center, Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD	Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.	1 year	Yes