Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden

Completed · Phase 2

Conditions studied: Multiple Myeloma, Primary Amyloidosis

In brief

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 of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.

Key facts

Study ID

NCT00651937

Run by

M.D. Anderson Cancer Center

People needed

80

Starts

2008-03-01

Expected to finish

2016-01-01

Last updated by the study team

2020-01-14

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients unable to perform MDASI assessments due to language or cultural barriers.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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