MyelomaPhase 3NCT01413178
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
A Phase 3 study testing Busulfan, Melphalan and Questionnaire in people with 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 compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myeloma
- What is being tested?
- Busulfan, Melphalan and Questionnaire
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2011to 10 Mar 2019
- Phase
- Phase 3
- 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 complete remission (CR), partial remission (PR), or very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain MM detected in the serum by free light chain assay.
- Patients with non-secretory multiple myeloma [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis (SPEP) and immunofixation (SIFE) and the absence of Bence Jones protein in the urine (UPEP) defined by use of conventional electrophoresis and immunofixation (UIFE) techniques] but with measurable disease on imaging studies like MRI, CT scan or PET scan.
- Who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
- 70 years of age or younger.
- Karnofsky performance score 70% or higher.
- Cardiac function: left ventricular ejection fraction at rest > 40% within 3 months of registration.
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- Hepatic function: bilirubin < 2x the upper limit of normal and ALT and AST < 2.5x the upper limit of normal.
- Renal function: creatinine clearance of >/= 40 mL/min, estimated or calculated.
- Pulmonary function: DLCO, FEV1, FVC >/= 50% of predicted value (corrected for hemoglobin) within 3 months of registration
- Signed informed consent form.
Who cannot join
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- Patients seropositive for the human immunodeficiency virus (HIV).
- Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patients participating in an investigational new drug protocol within 14 days before enrollment.
- Female patients who are pregnant (positive b-HCG) or breastfeeding.
- Prior stem cell transplantation allogeneic or autologous.
- Prior organ transplant requiring immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied.
Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.
- Group 1 will receive melphalan and busulfan.
- Group 2 will receive melphalan.
Both groups will have a stem cell transplant.
Study Drug Administration:
If you are in Group 1, you will first receive an additional low-level "test" dose of busulfan given by vein to check how your blood levels change over time. This information will be used to decide the next dose that is needed to reach a target blood level of busulfan. Blood (about 1 teaspoon each time) will be drawn up to 11 times during the next 11 hours after the test dose and the first high-dose busulfan treatment.
A heparin lock line will be placed in a vein to lower the number of needle sticks needed for these draws.
This test dose of busulfan can be given as an outpatient before you are admitted to the hospital, or you will be admitted on Day -10 (10 days before your transplant) and will receive the test dose on Day -9. If it is not possible for these blood level tests to be performed for technical or scheduling reasons, you will receive the standard, fixed (unchanging) dose of busulfan.
Eight (8) or 10 days before the transplant, you will be admitted to the hospital and given hydration fluids by vein.
On Days -7, -6, -5, and -4, you will receive busulfan by vein over 3 hours. You will receive melphalan on Days -2 and -1 by vein over 30 minutes. You will receive the stem cell transplant through the CVC on Day 0.
If you are in Group 2, you may be admitted to the hospital 3 days before the transplant. You will receive hydration fluids by vein. Two (2) days before the transplant, you will receive melphalan by vein over 30 minutes. You will not receive melphalan the day before the transplant.
Stem Cell Transplant:
The day that you receive the stem cell transplant is called Day 0. The stem cells will be given by vein through the CVC. The cells will travel to your bone marrow where they are designed to start making healthy, new blood cells after several weeks. You will sign a separate consent for the collection of your stem cells.
Beginning 5 days after the transplant, you will receive filgrastim (G-CSF) through a needle under your skin 1 time each day until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.
You will be in the hospital after the transplant for about 2-4 weeks.
Questionnaire:
You will be asked to complete a quality-of-life questionnaire before starting the study drugs and then once a week during Weeks 1, 2, and 4 after the stem cell transplant. The questionnaire will take about 15 minutes to complete.
Follow-Up Visits:
About 3 months after the transplant, you will have a bone marrow aspiration and biopsy to check the status of the disease. To collect a bone marrow aspiration and biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
Every 3 months during the first year after the transplant, blood (about 1-2 tablespoons) will be drawn to check your immune response and status of the disease.
About 1 year after the transplant, you will have a bone scan if the doctor thinks it is needed.
Length of Study:
One (1) year after the transplant, your participation in this study will be over.
If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have intolerable side effects after you receive chemotherapy, then you will still have the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed.
This is an investigational study. Busulfan and melphalan are commercially available and FDA approved for the treatment of myeloma. The use of melphalan alone before an autologous stem cell transplant is considered standard of care. Using busulfan with melphalan is investigational.
Up to 205 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Light chain Multiple Myeloma, MM, Autologous Hematopoietic Stem Cell Transplantation, Busulfan, Busulfex, Myleran, Melphalan, Alkeran, G-CSF, Filgrastim, NeupogenTM, Questionnaire, Survey, Quality of Life, QOL
- Medical subject headings
- Neoplasms, Plasma Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Busulfex, Myleran
Test dose (32 mg/m^2) on day -9 then 130 mg/m^2 by vein or adjusted dose on Days -7, -6, -5, and -4.
MelphalanDrug
Also called Alkeran
70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.
QuestionnaireOther
Also called Survey
Quality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete.
G-CSFDrug
Also called Filgrastim, NeupogenTM
Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.
High Dose MelphalanDrug
Also called Alkeran
200 mg/m2 by vein over 30 minutes on Day -2.
Stem cell transplantProcedure or surgery
Also called ABMT, autologous bone marrow transplantation, Peripheral Blood Progenitor Cells, PBPCs
Stem cell infusion on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Busulfan + Melphalan | Experimental | Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0. Receives: Drug: Busulfan; Drug: Melphalan; Other: Questionnaire; Drug: G-CSF; Procedure: Stem cell transplant |
| Melphalan | Experimental | High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0. Receives: Other: Questionnaire; Drug: G-CSF; Drug: High Dose Melphalan; Procedure: Stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.
Measured: 3 years after transplant
Secondary outcomes (4)
Number of Participants With Complete Response (CR)
Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria.
Measured: Evaluated 90 days from transplant.
Treatment-Related Mortality (TRM) Between 2 Arms.
Measured: 100 days post treatment
Number of Participants That Had Grade 3-4 Toxicities.
Measured: At day 90 post SCT (Stem Cell Transplantation)
Overall Survival (OS)
Measured: From time of ASCT to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study start30 Sep 2011
- Primary completion10 Mar 2019
- Study completion10 Mar 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 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, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413178
- Sponsor's protocol ID
- 2010-0071
- Other IDs
- NCI-2011-02760
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2011
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bashir Q, Thall PF, Milton DR, Fox PS, Kawedia JD, Kebriaei P, Shah N, Patel K, Andersson BS, Nieto YL, Valdez BC, Parmar S, Rondon G, Delgado R, Hosing C, Popat UR, Oran B, Ciurea SO, Lin P, Weber DM, Thomas SK, Lee HC, Manasanch EE, Orlowski RZ, Williams LA, Champlin RE, Qazilbash MH. Conditioning with busulfan plus melphalan versus melphalan alone before autologous haemopoietic cell transplantation for multiple myeloma: an open-label, randomised, phase 3 trial. Lancet Haematol. 2019 May;6(5):e266-e275. doi: 10.1016/S2352-3026(19)30023-7. Epub 2019 Mar 22.
PubMed 30910541
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01413178
- Acronym / sponsor ID
- 2010-0071
- Conditions
- Myeloma
- Keywords
- Myeloma, Multiple Myeloma, Light chain Multiple Myeloma, MM, Autologous Hematopoietic Stem Cell Transplantation, Busulfan, Busulfex, Myleran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 30 Sep 2011 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Posted 21 Apr 2020
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 compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied.
Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.
- Group 1 will receive melphalan and busulfan.
- Group 2 will receive melphalan.
Both groups will have a stem cell transplant.
Study Drug Administration:
If you are in Group 1, you will first receive an additional low-level "test" dose of busulfan given by vein to check how your blood levels change over time. This information will be used to decide the next dose that is needed to reach a target blood level of busulfan. Blood (about 1 teaspoon each time) will be drawn up to 11 times during the next 11 hours after the test dose and the first high-dose busulfan treatment.
A heparin lock line will be placed in a vein to lower the number of needle sticks needed for these draws.
This test dose of busulfan can be given as an outpatient before you are admitted to the hospital, or you will be admitted on Day -10 (10 days before your transplant) and will receive the test dose on Day -9. If it is not possible for these blood level tests to be performed for technical or scheduling reasons, you will receive the standard, fixed (unchanging) dose of busulfan.
Eight (8) or 10 days before the transplant, you will be admitted to the hospital and given hydration fluids by vein.
On Days -7, -6, -5, and -4, you will receive busulfan by vein over 3 hours. You will receive melphalan on Days -2 and -1 by vein over 30 minutes. You will receive the stem cell transplant through the CVC on Day 0.
If you are in Group 2, you may be admitted to the hospital 3 days before the transplant. You will receive hydration fluids by vein. Two (2) days before the transplant, you will receive melphalan by vein over 30 minutes. You will not receive melphalan the day before the transplant.
Stem Cell Transplant:
The day that you receive the stem cell transplant is called Day 0. The stem cells will be given by vein through the CVC. The cells will travel to your bone marrow where they are designed to start making healthy, new blood cells after several weeks. You will sign a separate consent for the collection of your stem cells.
Beginning 5 days after the transplant, you will receive filgrastim (G-CSF) through a needle under your skin 1 time each day until your blood cell levels return to normal. Filgrastim is designed to help with the growth of white blood cells.
You will be in the hospital after the transplant for about 2-4 weeks.
Questionnaire:
You will be asked to complete a quality-of-life questionnaire before starting the study drugs and then once a week during Weeks 1, 2, and 4 after the stem cell transplant. The questionnaire will take about 15 minutes to complete.
Follow-Up Visits:
About 3 months after the transplant, you will have a bone marrow aspiration and biopsy to check the status of the disease. To collect a bone marrow aspiration and biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
Every 3 months during the first year after the transplant, blood (about 1-2 tablespoons) will be drawn to check your immune response and status of the disease.
About 1 year after the transplant, you will have a bone scan if the doctor thinks it is needed.
Length of Study:
One (1) year after the transplant, your participation in this study will be over.
If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have intolerable side effects after you receive chemotherapy, then you will still have the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant doctor decides it is needed.
This is an investigational study. Busulfan and melphalan are commercially available and FDA approved for the treatment of myeloma. The use of melphalan alone before an autologous stem cell transplant is considered standard of care. Using busulfan with melphalan is investigational.
Up to 205 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Busulfan + Melphalan | Experimental | Drug: Busulfan, Drug: Melphalan, Other: Questionnaire, Drug: G-CSF, Procedure: Stem cell transplantBusulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0. |
| Melphalan | Experimental | Other: Questionnaire, Drug: G-CSF, Drug: High Dose Melphalan, Procedure: Stem cell transplantHigh-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with multiple myeloma in complete remission (CR), partial remission (PR), or very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain MM detected in the serum by free light chain assay.
- Patients with non-secretory multiple myeloma [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis (SPEP) and immunofixation (SIFE) and the absence of Bence Jones protein in the urine (UPEP) defined by use of conventional electrophoresis and immunofixation (UIFE) techniques] but with measurable disease on imaging studies like MRI, CT scan or PET scan.
- Who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
- 70 years of age or younger.
- Karnofsky performance score 70% or higher.
Key exclusion criteria (7 listed)
- Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- Patients seropositive for the human immunodeficiency virus (HIV).
- Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patients participating in an investigational new drug protocol within 14 days before enrollment.
- Female patients who are pregnant (positive b-HCG) or breastfeeding.
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 |
|---|---|---|
| BusulfanAlso: Busulfex, MyleranTest dose (32 mg/m^2) on day -9 then 130 mg/m^2 by vein or adjusted dose on Days -7, -6, -5, and -4. | Drug | Busulfan + Melphalan |
| MelphalanAlso: Alkeran70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1. | Drug | Busulfan + Melphalan |
| QuestionnaireAlso: SurveyQuality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete. | Other | Busulfan + Melphalan, Melphalan |
| G-CSFAlso: Filgrastim, NeupogenTMApproximately 5 mcg/kg/day subcutaneously beginning on Day +5. | Drug | Busulfan + Melphalan, Melphalan |
| High Dose MelphalanAlso: Alkeran200 mg/m2 by vein over 30 minutes on Day -2. | Drug | Melphalan |
| Stem cell transplantAlso: ABMT, autologous bone marrow transplantation, Peripheral Blood Progenitor Cells, PBPCsStem cell infusion on Day 0. | Procedure or surgery | Busulfan + Melphalan, Melphalan |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 3 years after transplant
Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.
4 secondary outcomes
Number of Participants With Complete Response (CR)
Time frame: Evaluated 90 days from transplant.
Treatment-Related Mortality (TRM) Between 2 Arms.
Time frame: 100 days post treatment
Number of Participants That Had Grade 3-4 Toxicities.
Time frame: At day 90 post SCT (Stem Cell Transplantation)
Overall Survival (OS)
Time frame: From time of ASCT to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30910541Bashir Q, Thall PF, Milton DR, Fox PS, Kawedia JD, Kebriaei P, Shah N, Patel K, Andersson BS, Nieto YL, Valdez BC, Parmar S, Rondon G, Delgado R, Hosing C, Popat UR, Oran B, Ciurea SO, Lin P, Weber DM, Thomas SK, Lee HC, Manasanch EE, Orlowski RZ, Williams LA, Champlin RE, Qazilbash MH. Conditioning with busulfan plus melphalan versus melphalan alone before autologous haemopoietic cell transplantation for multiple myeloma: an open-label, randomised, phase 3 trial. Lancet Haematol. 2019 May;6(5):e266-e275. doi: 10.1016/S2352-3026(19)30023-7. Epub 2019 Mar 22.
- University of Texas MD Anderson Cancer Center WebsiteLink 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
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 3 study testing Busulfan, Melphalan and Questionnaire 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 10 inclusion and 7 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 21 Apr 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 21 Apr 2020). 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?
Progression-Free Survival (PFS) (time frame: 3 years after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413178, which also lists 1 linked publication.
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 21 Apr 2020.