At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis
In Brief
A Phase 2 clinical trial evaluating Melphalan, Stem Cell Infusion, and 3 other interventions for Multiple Myeloma and Primary Amyloidosis. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
100 mg/m\^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.
Stem Cell Infusion is Day 0. Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10\^6 CD34/kg On Day 0 High Dose (Arm 2) = Stem cell dose of between 10-15 x 10\^6 CD34/kg On Day 0.
Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.
Collection of stem cells from blood collected either through CVC or from a vein in one arm.