Reduced Intensity Allogeneic PBSCT to Treat Hematologic Malignancies and Hematopoietic Failure States

Multiple Myeloma Clinical Trial

— ALBUM  

Official title:

A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997386
• Other study ID #: 09-0679-04
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: January 2016

Study information

• Verified date: September 2019
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.

Description:

Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2016
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in first complete remission or first chronic phase; and/or presence of one or more medical conditions that would place the subject at high risk such as heart and kidney disease.

• Subjects with hematologic cancers must have received at least one previous course of chemotherapy or biological therapy. In other words, the subject cannot enroll in this trial for initial treatment of the disease.

• Availability of a healthy related or unrelated volunteer allogeneic donor.

Exclusion Criteria:

• Eligible for another study or standard of care treatment that offers higher probability of cure or long-term control of subject's disease.

• Severe abnormal function of organs such as heart, kidneys, liver.

• Untreated or progressive central nervous system involvement by the disease.

• Subject is pregnant or breast-feeding.

• Performance score is below 50: at the least, requires considerable assistance and frequent medical care.

• Positive for the HIV [AIDS] virus

• Life expectancy less than 12 weeks with conventional treatments.

• For subjects capable of having children, refusal to practice birth control while on this study and for at least 12 months after PBSCT or after stopping post-transplant immunosuppressive treatments, whichever occurs later.

Related Conditions & MeSH terms

• Anemia, Aplastic
• Hematologic Neoplasms
• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Multiple Myeloma
• Myelofibrosis
• Neoplasms
• Primary Myelofibrosis

Intervention

Drug:
• busulfan, and melphalan, and alemtuzumab
intravenous busulfan 3.2 mg/kg/dose daily for 2 days, on days -5 and -4 (i.e., 5 and 4 days, respectively, before PBSCT). intravenous melphalan 100 mg/m2 on day -3. intravenous alemtuzumab 30 mg/dose for 2 days, on days -2 and -1.

Locations

Country	Name	City	State
United States	University Medical Center and UMC-North Clinic	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Presence of Donor Lymphohematopoietic Chimerism (Defined as at Least 50% Donor Cells in the Peripheral Blood) in Peripheral Blood by Day +100 (i.e., 100 Days After Allogeneic PBSCT).	To determine the efficacy of related or unrelated allogeneic PBSC transplantation (PBSCT) using a preparative regimen of busulfan, melphalan and alemtuzumab, as measured by durable donor lymphohematopoietic cell engraftment. The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).	Day +100
Secondary	Number of Participants With Relapse-free Survival.	To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.	Day +100
Secondary	Number of Participants With Event-free Survival.	To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.	Day +100
Secondary	Number of Participants With Overall Survival.	To determine the safety of related or unrelated allogeneic PBSCT using a preparative regimen of busulfan, melphalan and alemtuzumab. The primary safety endpoint is non-relapse mortality at day +100.	Day +100