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Primary Objective:
1. Determine differences in post transplant symptom burden as measured by M.D. Anderson Symptom Inventory (MDASI) scores in older patients with myeloma, or patients with amyloidosis undergoing high dose melphalan therapy receiving high dose melphalan with either a standard CD34 cell dose of 4-6 x 10 e 6/kg or a high dose of CD34 cells of between 10-15 x 10 e 6/kg.
Secondary Objectives:
- Determine differences in neutrophil and platelet recovery rates in older patients with myeloma, or patients with amyloidosis undergoing high dose melphalan therapy with either a standard CD34 cell dose of 4-6 x 10 e 6/kg or a high dose of CD34 cells of between 10-15 x 10 e 6/kg.
- Determine differences in cognitive function and measurements of physical assessment in older patients with myeloma, or patients with amyloidosis undergoing high dose melphalan therapy with either a standard CD34 cell dose of 4-6 x 10 e 6/kg or a high dose of CD34 cells of between 10-15 x 10 e 6/kg.
- Determine differences in cytokine profiles and their correlation with symptom burden, cognitive function, and physical function in older patients with myeloma, or patients with amyloidosis undergoing high dose high dose melphalan with either a standard CD34 cell dose of 4-6 x 10 e 6/kg or a high dose of CD34 cells of between 10-15 x 10 e 6/kg.
Multiple Myeloma
Primary Amyloidosis
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Drug: Melphalan
Procedure: Stem Cell Infusion
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Phase II
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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| 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 |
Primary Outcome Measures:
- 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. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. [ Time Frame: 8 Years ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 8 Years ] [ 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) |
| 1: Active Comparator
Melphalan Stem Cell Infusion (Standard Dose) |
Drug: Melphalan
100 mg/m^2 CVC Over 15-20 Minutes x 2 Days Procedure: Stem Cell Infusion
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. |
| 2: Active Comparator
Melphalan Stem Cell Infusion (High Dose) |
Drug: Melphalan
100 mg/m^2 CVC Over 15-20 Minutes x 2 Days Procedure: Stem Cell Infusion
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. |
| Ages Eligible for Study: |
60 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Inclusion Criteria:
- Patients with Multiple Myeloma over the age of 60, or with a Charlson Comorbidity Score of greater or equal to 3 in any of the following disease categories: a) Primary Refractory Disease b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) OR
- Patients with Primary Amyloidosis.
- Zubrod PS of <2.
- 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.
Exclusion Criteria:
1) Patients unable to perform MDASI or cognitive assessments due to language or cultural barriers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651937
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| Contact: Sergio A. Giralt, MD |
713-794-5745 |
|
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| U.T.M.D. Anderson Cancer Center |
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| Houston, Texas, United States, 77030 |
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| Principal Investigator: Sergio A. Giralt, MD |
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| M.D. Anderson Cancer Center |
|
| Principal Investigator: |
Sergio A. Giralt, MD |
U.T.M.D. Anderson Cancer Center |
|
| Contact: Sergio A. Giralt, MD |
713-794-5745 |
|
|
|
| U.T.M.D. Anderson Cancer Center |
|
|
| Houston, Texas, United States, 77030 |
|
| Principal Investigator: Sergio A. Giralt, MD |
|
| M.D. Anderson Cancer Center |
|
| 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 |
| First Received: |
March 31, 2008 |
| Last Updated: |
March 31, 2008 |
| ClinicalTrials.gov Identifier: |
NCT00651937 |
| Health Authority: |
United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
| Multiple Myeloma |
| Primary Amyloidosis |
| Cytokine Modulation | |
|
| Melphalan |
| Transplant Induced Symptoms |
| Stem Cell Infusion | | Study placed in the following topic categories:
| Melphalan |
| Metabolic Diseases |
| Immunoproliferative Disorders |
| Hematologic Diseases |
| Primary Amyloidosis |
| Blood Coagulation Disorders |
| Vascular Diseases |
| Paraproteinemias | |
|
| Hemostatic Disorders |
| Multiple Myeloma |
| Amyloidosis |
| Hemorrhagic Disorders |
| Multiple myeloma |
| Metabolic disorder |
| Lymphoproliferative Disorders |
| Neoplasms, Plasma Cell | | Additional relevant MeSH terms:
| Amyloidosis |
| Neoplasms by Histologic Type |
| Molecular Mechanisms of Pharmacological Action |
| Immune System Diseases |
| Immunologic Factors |
| Blood Protein Disorders |
| Antineoplastic Agents |
| Physiological Effects of Drugs | |
|
| Immunosuppressive Agents |
| Pharmacologic Actions |
| Neoplasms |
| Therapeutic Uses |
| Myeloablative Agonists |
| Cardiovascular Diseases |
| Antineoplastic Agents, Alkylating |
| Alkylating Agents | |
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