Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00651937
First received: March 31, 2008
Last updated: June 13, 2013
Last verified: June 2013
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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:
Drug Information available for:
Melphalan
Melphalan hydrochloride
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Mean Symptom Severity Score [ Time Frame: At one week after infusion of high dose chemotherapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of patients receiving a higher stem cell dose who have a lower increase in mean symptom severity score at one week after infusion of high dose chemotherapy as compared to patients receiving the lower stem cell dose [ Time Frame: Baseline to one week post high dose chemotherapy ] [ Designated as safety issue: No ]
| 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:
Behavioral: Questionnaires
Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Other Names:
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:
Behavioral: Questionnaires
Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Other Names:
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:
- 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.
- FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease.
- 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.
- 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.
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: | June 13, 2013 |
| 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 June 13, 2013