Transplantation, HomologousPhase 2NCT00899847
Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
A Phase 2 study testing Autologous peripheral blood stem cells (auto-PBSC) transplantation, Allogeneic peripheral blood stem cells (allo-PBSC) transplantation and Filgrastim in people with Transplantation, Homologous and Transplantation, Autologous, run by Stanford University at 1 site in United States.
Trial summary
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplantation, Homologous, Transplantation, Autologous, Multiple Myeloma
- What is being tested?
- Autologous peripheral blood stem cells (auto-PBSC) transplantation, Allogeneic peripheral blood stem cells (allo-PBSC) transplantation and Filgrastim
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
PARTICIPANT INCLUSION CRITERIA
- Stage II-III multiple myeloma or have progression after initial treatment of Stage I disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included.
- Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at Stanford University Medical Center.
- 18 to ≤ 75 years of age
- Karnofsky Performance Status > 70%.
- Corrected Carbon monoxide diffusing capacity (Dlco) > 60%
- Left ventricle ejection fraction (LVEF) > 50%.
- Alanine aminotransferase (ALT) ≤ 2 x normal
- Aspartate aminotransferase (AST) ≤ 2 x normal
- Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease.
- Estimated creatinine clearance > 50 mL/min.
- Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor with one antigen/allele mismatch in (HLA-A, B, C or DRB1).
- Signed informed consent.
DONOR INCLUSION CRITERIA
- At least 17 years of age
- HIV-seronegative
- Must be capable of giving signed, informed consent
- No contraindication to the administration of filgrastim
- Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate
PARTICIPANT EXCLUSION CRITERIA
- Prior allogeneic hematopoietic cell transplantation
- Uncontrolled active infection
- Uncontrolled congestive heart failure or angina
- HIV-positive
- Pregnant or nursing
DONOR EXCLUSION CRITERIA
- Serious medical or psychological illness
- Pregnant or lactating
- Prior malignancies within the last 5 years except for non-melanoma skin cancers
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Read the detailed description
Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.
- Conditions
- Transplantation, Homologous, Transplantation, Autologous, Multiple Myeloma, Blood and Marrow Transplant (BMT)
- Being tested
- Autologous peripheral blood stem cells (auto-PBSC) transplantation, Allogeneic peripheral blood stem cells (allo-PBSC) transplantation, Filgrastim, Cyclophosphamide, Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous peripheral blood stem cells (auto-PBSC) transplantationProcedure or surgery
Also called auto-PBPC, Autologous peripheral blood progenitor cells (auto-PBPC) transplantation
Auto-PBSC ≥ 2 to 3 x 10e6 CD34+ cells/kg are intravenously (IV) infused as part of the combination stem cell therapy.
and allogeneic stem cells are administered intravenous (IV) infusion to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective
Allogeneic peripheral blood stem cells (allo-PBSC) transplantationProcedure or surgery
Also called allo-PBSC, Allogeneic peripheral blood progenitor cells (allo-PBPC) transplantation
Allo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy.
FilgrastimDrug
Also called Neupogen, Granulocyte colony-stimulating factor (G-CSF), r-metHuG-CSF
Filgrastim is administered subcutaneously (SC) at 10 µg/kg/day for auto-PBSC mobilization starting day 2 of mobilization until the last day of apheresis.
Filgrastim is administered SC at 5 µg/kg/day from Day 6 after auto-PBSC infusion to hematologic recovery.
Filgrastim is administered SC at 16 µg/kg/day for donor allo-PBSC mobilization at from Day - 4 to Day 0, prior to allo-PBSC collection.
CyclophosphamideDrug
Also called Ciclofosfamida, Ciclofosfamide, Claphene, CP monohydrate (CPM)
Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen.
MelphalanDrug
Also called L-Sarcolysin, L-phenylalanine mustard (L-PAM), L-Sarcolysin phenylalanine mustard, L-sarcolysine
Melphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion.
CyclosporineDrug
Also called Cyclosporin, Cyclosporin A, Ciclosporin, CSP
Cyclosporine is administered by mouth (PO) for allo-PBSC graft vs host disease (GvHD) prophylaxis at 5 mg/kg from Day -3 through Bay +56. Tacrolimus may substituted.
Total lymphoid irradiationRadiation
Also called TLI
Total lymphoid irradiation is administered at 80 centigrey (cGy) on Day -11 to -7; and Day -4 to -2 before alllo-PBSC infusion. TLI is also administered at 80 centigrey (cGy) x 2 on Day -1 before alllo-PBSC infusion.
Rabbit anti-thymocyte globulinBiological
Also called Thymoglobulin, ATG
ATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion.
Mycophenolate Mofetil 250mgDrug
Also called CellCept, MMF
MMF is administered at 15 mg/kg 3x/day by mouth (PO) after allo-PBSC through Day 40, followed by 10% dose reduction weekly (dose taper) through day 96, and adjusted if there is evidence of MMF-related GI toxicity or excessive myelosuppression
SolumedrolDrug
Also called Solumedin, Soludecadron
Solumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion
DiphenhydramineDrug
Also called Benadryl
Diphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions.
AcetaminophenDrug
Also called Tylenol
Acetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions.
HydrocortisoneDrug
Hydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions.
| Study group | Role | What they receive |
|---|---|---|
| Autologous-Allogeneic Peripheral Blood Stem Cell Transplant | Experimental | Study treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression. Receives: Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation; Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation; Drug: Filgrastim; Drug: Cyclophosphamide; Drug: Melphalan; Drug: Cyclosporine; Radiation: Total lymphoid irradiation; Biological: Rabbit anti-thymocyte globulin; Drug: Mycophenolate Mofetil 250mg; Drug: Solumedrol; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Graft Versus Host Disease (GvHD)
To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting
Measured: 2 years after the last participant is enrolled.
Secondary outcomes (7)
Median Time to Engraftment After Auto-PBSC Transplant
Engraftment is assessed as:
- Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia
- Platelet engraftment is > 20 x 10⁹/L after cytopenia
Measured: 1 month
Median Time to Engraftment After Allo-PBSC Transplant
Engraftment is assessed as:
- Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia
- Platelet engraftment is > 20 x 10⁹/L after cytopenia
Measured: 1 month
Overall Response Rate (ORR)
Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)
Measured: 1 year
Complete Response Rate (CRR)
Complete response rate (CRR) was assessed as all of:
- Negative immunoflixation on the serum and urine
- Disappearance of any soft tissue plasmacytomas
- < 5% plasma cells in bone marrow
Measured: 1 year
Partial Response Rate (PRR)
Partial response rate (PRR) was assessed as
- > 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr
- If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain
- If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma.
Measured: 1 year
Event-free Survival (EFS)
To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)
Measured: 2 years after the last participant is enrolled
Overall Survival (OS)
To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)
Measured: 2 years after the last participant is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2014
- Study completionDec 2014
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 Transplantation, HomologousStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Kai Weng, Stanford University
- Investigators
- Wen-Kai Weng, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899847
- Sponsor's protocol ID
- IRB-15772
- Other IDs
- SU-04142009-2259, BMT201
- Status last verified
- Sep 2017
- First submitted
- 8 May 2009
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT00899847
- Acronym / sponsor ID
- IRB-15772
- Conditions
- Transplantation, Homologous, Transplantation, Autologous, Multiple Myeloma, Blood and Marrow Transplant (BMT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Detailed description
Development of cell-based immunotherapy from allogeneic hematopoietic cell transplantation (HCT) is dependent upon stable T-cell engraftment and the success of this therapeutic approach is likely to be greatest when directed against a minimal rather than gross tumor burden. To this end, tandem transplants with high dose therapy and autologous hematopoietic cell transplantation (AHCT) for tumor cytoreduction followed by non-myeloablative allotransplant have been conducted. In myeloma, this tandem approach results in greater efficacy compared to conventional AHCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous-Allogeneic Peripheral Blood Stem Cell Transplant | Experimental | Procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation, Procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation, Drug: Filgrastim, Drug: Cyclophosphamide, Drug: Melphalan, Drug: Cyclosporine, Radiation: Total lymphoid irradiation, Biological: Rabbit anti-thymocyte globulin, Drug: Mycophenolate Mofetil 250mg, Drug: Solumedrol, Drug: Diphenhydramine, Drug: Acetaminophen, Drug: HydrocortisoneStudy treatment is a high-dose sequential chemotherapy approach to hematopoietic stem cell (HSC) transplant that uses an autologous peripheral blood stem cell (auto-PBSC) transplant followed by allogeneic peripheral blood stem cell (allo-PBSC) transplant to evaluate improved graft vs host disease (GvHD) control. Participant auto-PBSC are mobilized with cyclophosphamide (also to provide cytoreduction) and filgrastim, followed by melphalan as an auto-PBSC conditioning agent, then auto-PBSC infusion. For the allo-PBSC transplant, donors are mobilized with filgrastim, and participants receive a regimen of total lymphoid irradiation and anti-thymocyte globulin (TLI/ATG), followed by infusion of donor allo-PBSC. Solumedrol, diphenhydramine, acetaminophen, and hydrocortisone are administered as premedications, and rabbit anti-thymocyte globulin (ATG) plus mycophenolate mofetil (MMF) are administered for post-allo-PBSC immunosuppression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Autologous peripheral blood stem cells (auto-PBSC) transplantationAlso: auto-PBPC, Autologous peripheral blood progenitor cells (auto-PBPC) transplantationAuto-PBSC ≥ 2 to 3 x 10e6 CD34+ cells/kg are intravenously (IV) infused as part of the combination stem cell therapy. and allogeneic stem cells are administered intravenous (IV) infusion to reestablish hematopoietic function in patients whose bone marrow or immune system is damaged or defective | Procedure or surgery | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| Allogeneic peripheral blood stem cells (allo-PBSC) transplantationAlso: allo-PBSC, Allogeneic peripheral blood progenitor cells (allo-PBPC) transplantationAllo-PBSC (target collection ≥ 5 x 10e6 CD34+ cells/kg) are intravenously (IV) infused as part of the combination stem cell therapy. | Procedure or surgery | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| FilgrastimAlso: Neupogen, Granulocyte colony-stimulating factor (G-CSF), r-metHuG-CSFFilgrastim is administered subcutaneously (SC) at 10 µg/kg/day for auto-PBSC mobilization starting day 2 of mobilization until the last day of apheresis. Filgrastim is administered SC at 5 µg/kg/day from Day 6 after auto-PBSC infusion to hematologic recovery. Filgrastim is administered SC at 16 µg/kg/day for donor allo-PBSC mobilization at from Day - 4 to Day 0, prior to allo-PBSC collection. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| CyclophosphamideAlso: Ciclofosfamida, Ciclofosfamide, Claphene, CP monohydrate (CPM)Cyclophosphamide is administered intravenously (IV) at 4 g/m2 on Day 1 of the auto-PBSC mobilization regimen. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| MelphalanAlso: L-Sarcolysin, L-phenylalanine mustard (L-PAM), L-Sarcolysin phenylalanine mustard, L-sarcolysineMelphalan is administered after CSP at 200 mg/m2 intravenously (IV) on Day -2 before auto-PBSC infusion. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| CyclosporineAlso: Cyclosporin, Cyclosporin A, Ciclosporin, CSPCyclosporine is administered by mouth (PO) for allo-PBSC graft vs host disease (GvHD) prophylaxis at 5 mg/kg from Day -3 through Bay +56. Tacrolimus may substituted. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| Total lymphoid irradiationAlso: TLITotal lymphoid irradiation is administered at 80 centigrey (cGy) on Day -11 to -7; and Day -4 to -2 before alllo-PBSC infusion. TLI is also administered at 80 centigrey (cGy) x 2 on Day -1 before alllo-PBSC infusion. | Radiation | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| Rabbit anti-thymocyte globulinAlso: Thymoglobulin, ATGATG 1.5 mg/kg is administered intravenously (IV) on Day -11 to -7 before allo-PBSC infusion. | Biological | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| Mycophenolate Mofetil 250mgAlso: CellCept, MMFMMF is administered at 15 mg/kg 3x/day by mouth (PO) after allo-PBSC through Day 40, followed by 10% dose reduction weekly (dose taper) through day 96, and adjusted if there is evidence of MMF-related GI toxicity or excessive myelosuppression | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| SolumedrolAlso: Solumedin, SoludecadronSolumedrol 1 mg/kg is administered intravenously (IV) on Day -11 to -7 as a premedication for ATG and allo-PBSC infusion | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| DiphenhydramineAlso: BenadrylDiphenhydramine 25 to 50 mg is administered as a premedication for the ATG; allo-PBSC; and DLI infusions. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| AcetaminophenAlso: TylenolAcetaminophen 650 mg is administered as a premedication for the ATG and allo-PBSC infusions. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
| HydrocortisoneHydrocortisone 100 mg is administered intravenously (IV) is a premedication for the allo-PBSC and DLI infusions. | Drug | Autologous-Allogeneic Peripheral Blood Stem Cell Transplant |
Primary outcome
Incidence of Graft Versus Host Disease (GvHD)
Time frame: 2 years after the last participant is enrolled.
To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting
7 secondary outcomes
Median Time to Engraftment After Auto-PBSC Transplant
Time frame: 1 month
Median Time to Engraftment After Allo-PBSC Transplant
Time frame: 1 month
Overall Response Rate (ORR)
Time frame: 1 year
Complete Response Rate (CRR)
Time frame: 1 year
Partial Response Rate (PRR)
Time frame: 1 year
Event-free Survival (EFS)
Time frame: 2 years after the last participant is enrolled
Overall Survival (OS)
Time frame: 2 years after the last participant is enrolled
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Wen-Kai Weng principal investigator
Stanford University
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 Autologous peripheral blood stem cells (auto-PBSC) transplantation, Allogeneic peripheral blood stem cells (allo-PBSC) transplantation and Filgrastim in people with Transplantation, Homologous and Transplantation, Autologous, run by Stanford University 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?
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 20 Oct 2017. 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 20 Oct 2017). 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?
Incidence of Graft Versus Host Disease (GvHD) (time frame: 2 years after the last participant is enrolled.). 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 20 Oct 2017.