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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00651937 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
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Multiple Myeloma Primary Amyloidosis |
Drug: Melphalan Procedure: Stem Cell Infusion Behavioral: Questionnaires Drug: Granulocyte-colony stimulating factor (G-CSF) Procedure: Apheresis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
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1: Active Comparator
Melphalan + Stem Cell Infusion (Standard Dose)
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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.
Procedure: Stem Cell Infusion
Stem Cell Infusion is Day 0. Arm 1 = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 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.
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.
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2: Active Comparator
Melphalan + Stem Cell Infusion (High Dose)
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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.
Procedure: Stem Cell Infusion
Stem Cell Infusion is Day 0. Arm 1 = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0 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.
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.
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Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1) Patients unable to perform MDASI or cognitive assessments due to language or cultural barriers.
Contact: Sergio A. Giralt, MD | 713-794-5745 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Sergio A. Giralt, MD |
Principal Investigator: | Sergio A. Giralt, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Sergio A. Giralt, MD/Professor ) |
Study ID Numbers: | 2005-0601 |
Study First Received: | March 31, 2008 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00651937 History of Changes |
Health Authority: | United States: Institutional Review Board |
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 |
Melphalan Metabolic Diseases Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Primary Amyloidosis Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Immunosuppressive Agents Multiple Myeloma Amyloidosis Hemorrhagic Disorders Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Alkylating Agents Metabolic Disorder Neoplasms, Plasma Cell |
Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Neoplasms by Histologic Type Metabolic Diseases |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Amyloidosis Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |