Status:
COMPLETED
Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Multiple Myeloma
Primary Amyloidosis
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose o...
Detailed Description
Stem cells are found in the bone marrow and bloodstream, and they rebuild blood, bone marrow, and the immune system. This study uses autologous stem cells, which are stem cells collected from your own...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma over the age of 60 in any of the following disease categories: a) Primary refractory disease b) Consolidation of a first partial or complete remission. OR
- Patients with primary amyloidosis.
- Zubrod PS of \<2 or Karnofsky \>/= 70.
- Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) \>/= 40%. No symptomatic pulmonary disease.
- Serum bilirubin \</= 2 X upper limit of normal, serum glutamate pyruvate transaminase (SGPT) \</= 4 X upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites \>1L prior to drainage.
- HIV-negative.
- Patient is not pregnant.
- Patient or guardian able to sign informed consent.
- Have greater than or equal to 10 x 10 e 6 CD34+ cells per kg of autologous stem cells cryopreserved for stem cell transplantation, procured with 5 or fewer apheresis collections.
Exclusion
- 1\) Patients unable to perform MDASI assessments due to language or cultural barriers.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00651937
Start Date
March 1 2008
End Date
January 1 2016
Last Update
January 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030