TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma

November 6, 2018 updated by: M.D. Anderson Cancer Center

Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma

To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T. M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with intermediate or high tumor mass multiple myeloma with responsive or primary refractory disease; and patients with responsive or refractory relapse.
  2. Physiological age </= 70.
  3. Zubrod performance status < 3.
  4. Life expectancy greater than 12 weeks.
  5. Left ventricular ejection fraction >/= 50%.
  6. No uncontrolled arrythmias or symptomatic cardiac disease.
  7. FEV1, FVC and DLCO >/= 50%.
  8. No symptomatic pulmonary disease.
  9. Serum creatinine < 1.5 mg/dL.
  10. Serum bilirubin < 2x upper limit of normal.
  11. No evidence of chronic or active hepatitis or cirrhosis.
  12. Patient is not pregnant.
  13. Patients or guardian able to sign informed consent.
  14. No active CNS disease.
  15. Platelet count > 100K.

Exclusion Criteria:

1) N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • Cytoxan
  • Neosar
Drug: Melphalan
After stem cells are collected, Melphalan 70 mg/m^2/day intravenously given on Days 4 and 5.
Other Names:
  • Alkeran
Other: Peripheral Blood Stem Cells
On Day 7, some or all of the stem cells will be reinfused.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: Within 180 days after treatment
Within 180 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

SmithKline Beecham

Investigators

  • Principal Investigator: Michelle Donato, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2002

Primary Completion (Actual)

May 19, 2006

Study Completion (Actual)

May 19, 2006

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM01-331

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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