Multiple MyelomaPhase 2NCT00505895
FM 140 vs FM100 Study in Patients With Multiple Myeloma
A Phase 2 study testing Melphalan, Fludarabine and Stem Cell Infusion in people with Multiple Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Melphalan, Fludarabine and Stem Cell Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory considered poor candidate for autologous transplant, b) Remission Consolidation in patients with Chromosome 13 abnormalities or plasma cell leukemia, c) All relapsing patients.
- Age up to 70 years.
- Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C, DRB1 and DQ) by molecular techniques.
- Zubrod Performance Score (PS)<2.
- Life expectancy is not severely limited by concomitant illness. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) >40%.
- Patient and donor or guardian willing and able to sign informed consent.
Who cannot join
- 1) Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT MD . Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.
Read the detailed description
Fludarabine is a chemotherapy drug that is used in various diseases. Melphalan is a chemotherapy drug that has been widely used in the treatment of multiple myeloma for many years.
Before beginning therapy, patients will have a complete work-up. This includes a bone marrow aspiration and biopsy, bone survey, blood tests, and tests to check the heart and lung function. All patients will receive tacrolimus and methotrexate to prevent graft-versus-host disease.
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance that a patient will be in either group.
Patients in the first group will receive fludarabine through the vein every day for four days. On the fourth day, patients will receive a dose of melphalan through the vein over 20 minutes. On the following day, patients will receive the donor cells as an infusion through their catheter.
Patients in the second group will receive fludarabine through the vein every day for four days. Patients in this group will receive a lower dose of melphalan through the vein over 20 minutes. After the last dose of fludarabine, patients will receive the donor cells as an infusion through their catheter the next day.
If you have an unrelated or a mismatched donor, you will receive the drug ATG (Thymoglobulin) by vein over 6 hours on Days -3, -2, and -1 (the 3 days before the transplant), to prevent graft versus host disease (GVHD) and to help engraftment.
Patients in both group will be receiving the monoclonal antibody called rituximab weekly starting on the fifth day before the stem cell transplant for a total of 4 doses.
Patients will remain in the hospital for about 4-6 weeks and in Houston Medical Center area at least 100 days after transplantation.
Patients whose disease gets worse will be taken off study. These patients will continue to be followed for survival.
This is an investigational study. All of the drugs used in this study are commercially available. The FDA has approved melphalan for the treatment of myeloma. Fludarabine is not approved for the treatment of myeloma but has been used for years as a way to prepare patients for transplant. About 30 to 60 patients will take part in this study. About 45 patients will be enrolled at M. D. Anderson.
- Conditions
- Multiple Myeloma
- Being tested
- Melphalan, Fludarabine, Stem Cell Infusion, Rituximab
- Keywords
- Multiple Myeloma, Fludarabine, Fludara, Fludarabine Phosphate, Melphalan, Alkeran, Stem Cell Infusion, Stem Cell Transfusion, SCT, Allogeneic Peripheral Blood Stem Cell Transfusion, APBSCT, Bone Marrow Transplantation, BMT, Rituxan, Rituximab, FM140, FM100
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Alkeran
Arm 1 = 140 mg/m^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m^2 intravenous over 20 Minutes on Day -1.
FludarabineDrug
Also called Fludara, Fludarabine Phosphate
30 mg/m^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).
Stem Cell InfusionProcedure or surgery
Also called Allogeneic Peripheral Blood Stem Cell Transfusion, APBSCT, Bone Marrow Transplantation, BMT
Stem Cell Infusion on Day 0.
RituximabDrug
Also called Rituxan
375 mg/m^2 intravenous on Day -5, +2 +9 and +16.
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine + Melphalan + Stem Cell Infusion | Experimental | Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5. Receives: Drug: Melphalan; Drug: Fludarabine; Procedure: Stem Cell Infusion; Drug: Rituximab |
| Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion | Experimental | Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5. Receives: Drug: Melphalan; Drug: Fludarabine; Procedure: Stem Cell Infusion; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Engraftment at Day 100
Measured: Day 100
Secondary outcomes (1)
Acute Grade II-IV Graft Versus Host Disease (GVHD)
Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4.
Measured: GVHD grading weekly during first 100 days; Annual examinations for nine year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJan 2002
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muzaffar H. Qazilbash, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505895
- Sponsor's protocol ID
- ID01-518
- Status last verified
- Oct 2014
- First submitted
- 20 Jul 2007
- Last updated
- 17 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00505895
- Acronym / sponsor ID
- ID01-518
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Fludarabine, Fludara, Fludarabine Phosphate, Melphalan, Alkeran, Stem Cell Infusion, Stem Cell Transfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.
Detailed description
Fludarabine is a chemotherapy drug that is used in various diseases. Melphalan is a chemotherapy drug that has been widely used in the treatment of multiple myeloma for many years.
Before beginning therapy, patients will have a complete work-up. This includes a bone marrow aspiration and biopsy, bone survey, blood tests, and tests to check the heart and lung function. All patients will receive tacrolimus and methotrexate to prevent graft-versus-host disease.
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance that a patient will be in either group.
Patients in the first group will receive fludarabine through the vein every day for four days. On the fourth day, patients will receive a dose of melphalan through the vein over 20 minutes. On the following day, patients will receive the donor cells as an infusion through their catheter.
Patients in the second group will receive fludarabine through the vein every day for four days. Patients in this group will receive a lower dose of melphalan through the vein over 20 minutes. After the last dose of fludarabine, patients will receive the donor cells as an infusion through their catheter the next day.
If you have an unrelated or a mismatched donor, you will receive the drug ATG (Thymoglobulin) by vein over 6 hours on Days -3, -2, and -1 (the 3 days before the transplant), to prevent graft versus host disease (GVHD) and to help engraftment.
Patients in both group will be receiving the monoclonal antibody called rituximab weekly starting on the fifth day before the stem cell transplant for a total of 4 doses.
Patients will remain in the hospital for about 4-6 weeks and in Houston Medical Center area at least 100 days after transplantation.
Patients whose disease gets worse will be taken off study. These patients will continue to be followed for survival.
This is an investigational study. All of the drugs used in this study are commercially available. The FDA has approved melphalan for the treatment of myeloma. Fludarabine is not approved for the treatment of myeloma but has been used for years as a way to prepare patients for transplant. About 30 to 60 patients will take part in this study. About 45 patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fludarabine + Melphalan + Stem Cell Infusion | Experimental | Drug: Melphalan, Drug: Fludarabine, Procedure: Stem Cell Infusion, Drug: RituximabFludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4). Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5. |
| Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion | Experimental | Drug: Melphalan, Drug: Fludarabine, Procedure: Stem Cell Infusion, Drug: RituximabFludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4). Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory considered poor candidate for autologous transplant, b) Remission Consolidation in patients with Chromosome 13 abnormalities or plasma cell leukemia, c) All relapsing patients.
- Age up to 70 years.
- Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C, DRB1 and DQ) by molecular techniques.
- Zubrod Performance Score (PS)<2.
- Life expectancy is not severely limited by concomitant illness. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) >40%.
Key exclusion criteria (1 listed)
- 1) Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.
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 |
|---|---|---|
| MelphalanAlso: AlkeranArm 1 = 140 mg/m^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m^2 intravenous over 20 Minutes on Day -1. | Drug | Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion, Fludarabine + Melphalan + Stem Cell Infusion |
| FludarabineAlso: Fludara, Fludarabine Phosphate30 mg/m^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4). | Drug | Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion, Fludarabine + Melphalan + Stem Cell Infusion |
| Stem Cell InfusionAlso: Allogeneic Peripheral Blood Stem Cell Transfusion, APBSCT, Bone Marrow Transplantation, BMTStem Cell Infusion on Day 0. | Procedure or surgery | Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion, Fludarabine + Melphalan + Stem Cell Infusion |
| RituximabAlso: Rituxan375 mg/m^2 intravenous on Day -5, +2 +9 and +16. | Drug | Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion, Fludarabine + Melphalan + Stem Cell Infusion |
Primary outcome
Number of Participants With Successful Engraftment at Day 100
Time frame: Day 100
1 secondary outcome
Acute Grade II-IV Graft Versus Host Disease (GVHD)
Time frame: GVHD grading weekly during first 100 days; Annual examinations for nine year study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.Anderson Cancer CenterLink 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.
Muzaffar H. Qazilbash, MD principal investigator
UT MD 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 Melphalan, Fludarabine and Stem Cell Infusion in people with Multiple 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 6 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 17 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Engraftment at Day 100 (time frame: Day 100). 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 17 Oct 2014.