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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00651937
First received: March 31, 2008
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Primary Amyloidosis
Drug: Melphalan
Procedure: Stem Cell Infusion
Behavioral: Questionnaires
Drug: Granulocyte-colony stimulating factor (G-CSF)
Procedure: Apheresis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden in High Risk Patients With Multiple Myeloma or Amyloidosis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Mean Symptom Severity Scores: Differences in post transplant symptom burden as measured by MDASI scores [ Time Frame: Baseline up to 1 year post transplant ] [ Designated as safety issue: No ]
    MD Anderson Symptom Inventory (MDASI) 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 (e.g., fatigue, worrying, attention) 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).


Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Dose
Melphalan + Stem Cell Infusion (Standard Dose): Standard Dose (Arm 1) = Stem cell dose of between 4-6 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.
Drug: 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.
Other Name: Alkeran
Procedure: 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.

Other Names:
  • Autologous Stem Cell Transplant
  • ASCT
Behavioral: Questionnaires
Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Other Names:
  • Survey
  • Automated Phone Interview
  • M.D. Anderson Symptom Inventory
  • MDASI
Drug: Granulocyte-colony stimulating factor (G-CSF)
5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.
Procedure: Apheresis
Collection of stem cells from blood collected either through CVC or from a vein in one arm.
Active Comparator: High Dose
Melphalan + 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.
Drug: 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.
Other Name: Alkeran
Procedure: 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.

Other Names:
  • Autologous Stem Cell Transplant
  • ASCT
Behavioral: Questionnaires
Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Other Names:
  • Survey
  • Automated Phone Interview
  • M.D. Anderson Symptom Inventory
  • MDASI
Drug: Granulocyte-colony stimulating factor (G-CSF)
5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.
Procedure: Apheresis
Collection of stem cells from blood collected either through CVC or from a vein in one arm.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease.
  6. Serum bilirubin </= 2 X upper limit of normal, SGPT </= 4 X upper limit of normal. No evidence of chronic active hepatitis or 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651937

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Nina Shah, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00651937     History of Changes
Other Study ID Numbers: 2005-0601
Study First Received: March 31, 2008
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Primary Amyloidosis
Cytokine Modulation
Melphalan
Alkeran
Transplant Induced Symptoms
Stem Cell Infusion
Autologous stem cell transplant
ASCT
Granulocyte-colony stimulating factor
G-CSF
Apheresis

Additional relevant MeSH terms:
Amyloidosis
Multiple Myeloma
Neoplasms, Plasma Cell
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Lenograstim
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 17, 2014