TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma
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Purpose
To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloma |
Drug: Topotecan Drug: Cyclophosphamide Drug: Melphalan Other: Peripheral Blood Stem Cells |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma |
- Response Rate [ Time Frame: Within 180 days after treatment ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | February 2002 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TMC
Topotecan, Melphalan, and Cyclophosphamide
|
Drug: Topotecan
After stem cells are collected, Topotecan 3.5 mg/m^2 intravenously given over 30 minutes on Days 1 - 5.
Other Name: Hycamtin
Drug: Cyclophosphamide
After stem cells are collected, Cyclophosphamide 1 g/m^2/day intravenously given over 2 hours on Days 1 - 3.
Other Names:
Drug: Melphalan
After stem cells are collected, Melphalan 70 mg/m^2/day intravenously given on Days 4 and 5.
Other Name: Alkeran
Other: Peripheral Blood Stem Cells
On Day 7, some or all of the stem cells will be reinfused.
|
Detailed Description:
Patients in this study will have a catheter (a tube) placed in the vein below the collarbone. Most of the drugs used in the study will be given through the catheter. Blood stem cells will be collected through this tube also.
Before treatment starts, patients will have a complete physical exam, including blood and urine tests. A dentist will perform a dental exam either at M.D. Anderson or elsewhere. A chest x-ray and bone x-rays will be done. An EKG and a heart scan will be done to test heart function. A breathing test will be done. Patients will also be screened for HIV and Hepatitis.
Blood stem cells will be collected from patients when white blood cell counts are normal. This will be after earlier chemotherapy or after a bone marrow growth factor (G-CSF) has been given. Collecting stem cells takes about 3 hours. It takes from 1 to 6 sessions to get the needed amount of cells. The process is called apheresis. A machine is attached to the catheter, and blood is drawn. The machine removes the stem cells from the blood and the blood is then returned to the body through the catheter. G-CSF is injected under the skin twice a day during the time the stem cells are collected. The stem cells are stored frozen and will be used later to help patients recover from the high-dose chemotherapy.
After stem cells are collected, patients will receive high-dose chemotherapy. Cyclophosphamide is given over 2 hours on Days 1 - 3. Melphalan is given on Days 4 and 5. Topotecan is given over 30 minutes on Days 1 - 5, right after cyclophosphamide or melphalan. On Day 6, no drugs are given. On Day 7, some or all of the stem cells will be reinfused. G-CSF will be given once a day until blood counts return to normal.
Patients must stay in the hospital for the high-dose drug treatment. The length of stay will be about 3 weeks. Blood tests will be done daily while in hospital, then once a week for the first month. A bone marrow sample will be taken on Day 30. Blood samples will be taken 4 times in the first year and once a year after that. Thyroid gland tests and a bone marrow test will be done once a year.
This is an investigational study. Cyclophosphamide, melphalan, and topotecan are approved by the FDA. Their use together in this study is experimental. All participants will be enrolled at UTMDACC.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with intermediate or high tumor mass multiple myeloma with responsive or primary refractory disease; and patients with responsive or refractory relapse.
- Physiological age </= 70.
- Zubrod performance status < 3.
- Life expectancy greater than 12 weeks.
- Left ventricular ejection fraction >/= 50%.
- No uncontrolled arrythmias or symptomatic cardiac disease.
- FEV1, FVC and DLCO >/= 50%.
- No symptomatic pulmonary disease.
- Serum creatinine < 1.5 mg/dL.
- Serum bilirubin < 2x upper limit of normal.
- No evidence of chronic or active hepatitis or cirrhosis.
- Patient is not pregnant.
- Patients or guardian able to sign informed consent.
- No active CNS disease.
- Platelet count > 100K.
Exclusion Criteria:
1) N/A
Contacts and Locations| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Michelle Donato, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01039025 History of Changes |
| Other Study ID Numbers: | DM01-331 |
| Study First Received: | December 23, 2009 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Myeloma Topotecan Hycamtin Melphalan Alkeran |
Cyclophosphamide Cytoxan Neosar Stem Cell Harvest Peripheral Blood Stem Cells |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell 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 Cyclophosphamide |
Melphalan Topotecan Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013