Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis
2 other identifiers
interventional
80
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Mar 2008
Longer than P75 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
January 14, 2020
CompletedJanuary 14, 2020
January 1, 2020
7.8 years
March 31, 2008
April 9, 2019
January 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Symptom Severity Burden as Measured by MDASI Scores
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive symptoms on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10).
The first 7 days post-transplant.
Mean Symptom Severity Burden as Measured by MDASI Scores
MD Anderson Symptom Inventory (MDASI) Scale regularly administered during the first year following transplantation. This instrument is brief, easily understood, and provides a measure of the intensities of cancer-related symptoms. Participants rate the intensity of physical, affective, and cognitive on 0 to 10 numeric scales from "not present" (score of 0) to "as bad as you can imagine" (score of 10). Participants also rate amount of interference with daily activities caused by symptoms on 0 to 10 numeric scales from "did not interfere" (Score of 0) to interfered completely (score of 10)
28 day course of ASCT
Study Arms (2)
Standard Dose
ACTIVE COMPARATORMelphalan + Stem Cell Infusion (Standard Dose): Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10\^6 cluster of differentiation 34 (CD34)/kg on Day 0. Melphalan 100 mg/m\^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
High Dose
ACTIVE COMPARATORMelphalan + Stem Cell Infusion (High Dose): High Dose (Arm 2) = Stem cell dose of between 10-15 x 10\^6 CD34/kg On Day 0. Melphalan 100 mg/m\^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard E Champlin,MD/Chair, Stem Cell Transplantation
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Shah, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 3, 2008
Study Start
March 1, 2008
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 14, 2020
Results First Posted
January 14, 2020
Record last verified: 2020-01