MyelomaPhase 2NCT01039025
TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma
A Phase 2 study testing Topotecan, Cyclophosphamide and Melphalan in people with Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Myeloma
- What is being tested?
- Topotecan, Cyclophosphamide and Melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2002to 19 May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 1) N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Myeloma
- Being tested
- Topotecan, Cyclophosphamide, Melphalan, Peripheral Blood Stem Cells
- Keywords
- Myeloma, Topotecan, Hycamtin, Melphalan, Alkeran, Cyclophosphamide, Cytoxan, Neosar, Stem Cell Harvest, Peripheral Blood Stem Cells
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
Also called Hycamtin
After stem cells are collected, Topotecan 3.5 mg/m^2 intravenously given over 30 minutes on Days 1 - 5.
CyclophosphamideDrug
Also called Cytoxan, Neosar
After stem cells are collected, Cyclophosphamide 1 g/m^2/day intravenously given over 2 hours on Days 1 - 3.
MelphalanDrug
Also called Alkeran
After stem cells are collected, Melphalan 70 mg/m^2/day intravenously given on Days 4 and 5.
Peripheral Blood Stem CellsOther
On Day 7, some or all of the stem cells will be reinfused.
| Study group | Role | What they receive |
|---|---|---|
| TMC | Experimental | Topotecan, Melphalan, and Cyclophosphamide Receives: Drug: Topotecan; Drug: Cyclophosphamide; Drug: Melphalan; Other: Peripheral Blood Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: Within 180 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study start18 Feb 2002
- Primary completion19 May 2006
- Study completion19 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- SmithKline Beecham
- Responsible party
- Sponsor
- Investigators
- Michelle Donato, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039025
- Sponsor's protocol ID
- DM01-331
- Status last verified
- Nov 2018
- First submitted
- 23 Dec 2009
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of High-Dose Topotecan, Cyclophosphamide and Melphalan for the Treatment of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01039025
- Acronym / sponsor ID
- DM01-331
- Conditions
- Myeloma
- Keywords
- Myeloma, Topotecan, Hycamtin, Melphalan, Alkeran, Cyclophosphamide, Cytoxan, Neosar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- SmithKline Beecham
- Study start
- 18 Feb 2002 (actual)
- Primary completion
- 19 May 2006 (actual)
- Study completion
- 19 May 2006 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy of high-dose topotecan, cyclophosphamide and melphalan in patients with Multiple Myeloma.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMC | Experimental | Drug: Topotecan, Drug: Cyclophosphamide, Drug: Melphalan, Other: Peripheral Blood Stem CellsTopotecan, Melphalan, and Cyclophosphamide |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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%.
Key exclusion criteria (1 listed)
- 1) N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopotecanAlso: HycamtinAfter stem cells are collected, Topotecan 3.5 mg/m^2 intravenously given over 30 minutes on Days 1 - 5. | Drug | TMC |
| CyclophosphamideAlso: Cytoxan, NeosarAfter stem cells are collected, Cyclophosphamide 1 g/m^2/day intravenously given over 2 hours on Days 1 - 3. | Drug | TMC |
| MelphalanAlso: AlkeranAfter stem cells are collected, Melphalan 70 mg/m^2/day intravenously given on Days 4 and 5. | Drug | TMC |
| Peripheral Blood Stem CellsOn Day 7, some or all of the stem cells will be reinfused. | Other | TMC |
Primary outcome
Response Rate
Time frame: Within 180 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- M.D. Anderson Cancer Center clinical trials web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Donato, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topotecan, Cyclophosphamide and Melphalan in people with Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Within 180 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.