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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Lenograstim; Melphalan; Sargramostim

Criteria

Inclusion Criteria:

1. 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

2. Patients with primary amyloidosis.

3. Zubrod PS of <2 or Karnofsky >/= 70.

4. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

5. 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.

6. Serum bilirubin(SGPT)cirrhosis. No effusion or ascites >1L prior to drainage.

7. HIV-negative.

8. Patient is not pregnant.

9. Patient or guardian able to sign informed consent.

10. 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 Criteria:

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