Refractory Multiple MyelomaPhase 1/2NCT00054353
Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma
A Phase 1/2 study testing fludarabine phosphate, melphalan and total-body irradiation in people with Refractory Multiple Myeloma, run by Fred Hutchinson Cancer Center at 2 sites in 2 countries.
Trial summary
This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Multiple Myeloma
- What is being tested?
- fludarabine phosphate, melphalan and total-body irradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2002to 14 Oct 2012
- Phase
- Phase 1/2
- 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
- Meet Salmon and Durie criteria for initial diagnosis of MM; transplant will be offered to patients with previously treated MM who meet one of the following criteria:
- Patient received at least one prior autologous or syngeneic hematopoietic SCT (HSCT) and now has progressive disease (PD) (greater than 25% increase in serum or urine paraprotein levels compared to best response status after autograft or appearance of new lytic bone lesions or plasmocytomas)
- Patient is not able to collect autologous PBSC due to poor marrow reserve (insufficient HSC-mobilization: < 2.5 x 10^6 cluster of differentiation [CD]34+ cells/kg); or contraindications to undergoing HSC-mobilization; patient now has PD and has received at least 4 cycles of standard chemotherapy (e.g. vincristine sulfate, doxorubicin hydrochloride, and dexamethasone [VAD]) in the past
- Patients must have the capacity to give informed consent
- DONOR: Human leukocyte antigen (HLA) genotypically identical sibling or phenotypically matched relative
- DONOR: HLA phenotypically matched unrelated donor (according to Standard Practice HLA matching criteria)
Show all 10Show fewer
- Matched for serologically recognized HLA-A or B or C antigens and at least five of six HLA-A or B or C alleles
- Matched for HLA DRB1 and DQB1 alleles (defined by high-resolution typing) at the allele level
- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for PBSC collection
- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of a temporary central venous catheter
Who cannot join
- Karnofsky score < 60%
- Left ventricular ejection fraction < 40% or symptomatic heart failure; ejection fraction is required if age > 50 years or there is a history of anthracycline exposure or history of cardiac disease
- Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL,or symptomatic biliary disease
- Diffusion capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen
- Creatinine clearance < 40 mL/min
- Patients with poorly controlled hypertension
Show all 29Show fewer
- Seropositive for the human immunodeficiency virus (HIV)
- Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence
- Pregnancy or breastfeeding
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Not fully recovered from previous high-dose therapy:
- Persistent mucositis and gastrointestinal symptoms requiring hyperalimentation and/or intravenous hydration
- On steroids for autologous/syngeneic GVHD
- On IV antibiotics for documented infections
- Cytomegalovirus (CMV)-antigenemia positive
- On ganciclovir or foscarnet for previous CMV reactivation/infection; off of this therapy for less than two weeks despite documented CMV-antigenemia- negativity (identification [ID] should be consulted if there is persistent CMV antigenemia post autograft)
- Ongoing radiotherapy
- Patients who meet any of these criteria may be discussed with the principal investigator for recommendations as to the timing of the allograft
- Patients with active bacterial or fungal infections unresponsive to medical therapy
- DONOR: Identical twin
- DONOR: Donors unwilling to donate PBSC
- DONOR: Pregnancy
- DONOR: Infection with HIV
- DONOR: Inability to achieve adequate venous access
- DONOR: Known allergy to G-CSF
- DONOR: Current serious systemic illness
- DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation
- DONOR: Age < 12 years
- DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial
This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of this approach by determining the 1-year progression-free survival (PFS) and overall survival (OS).
II. To evaluate day 100 non-relapse mortality.
III. To determine the incidences of grades II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donors).
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months, and then annually thereafter for 5 years.
- Conditions
- Refractory Multiple Myeloma
- Being tested
- fludarabine phosphate, melphalan, total-body irradiation, mycophenolate mofetil, cyclosporine
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called 2-F-ara-AMP, Beneflur, Fludara
Given IV
melphalanDrug
Also called Alkeran, CB-3025, L-PAM, L-phenylalanine mustard
Given IV
total-body irradiationRadiation
Also called TBI
Undergo TBI
Also called Cellcept, MMF
Given PO
cyclosporineDrug
Also called ciclosporin, cyclosporin, cyclosporin A, CYSP
Given PO
nonmyeloablative allogeneic hematopoietic stem cell transplantationProcedure or surgery
Undergo reduced-intensity allogeneic PBSCT
peripheral blood stem cell transplantationProcedure or surgery
Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Undergo reduced-intensity allogeneic PBSCT
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Related Donor | Experimental | PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). Receives: Drug: fludarabine phosphate; Drug: melphalan; Radiation: total-body irradiation; Drug: mycophenolate mofetil; Drug: cyclosporine; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Other: laboratory biomarker analysis |
| Unrelated Donor | Experimental | PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). Receives: Drug: fludarabine phosphate; Drug: melphalan; Radiation: total-body irradiation; Drug: mycophenolate mofetil; Drug: cyclosporine; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.
Measured: At 1 year post-transplant
Non-relapse Mortality
Early NRM will be monitored in a sequential fashion.
Measured: At day 100
Incidence of Acute GVHD (Grades III-IV)
Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
Measured: Up to 5 years
Incidence of Chronic (Extensive) GVHD
Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
Measured: Up to 5 years
Secondary outcomes (4)
OS
Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.
Measured: At 6 months and then every year thereafter, up to 5 years
Engraftment
Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion.
Measured: Up to 5 years
Relapse Rate
Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates.
Measured: Up to 5 years
Response Rate
Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startOct 2002
- Primary completionOct 2009
- Study completion14 Oct 2012
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 Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marco Mielcarek, Fred Hutchinson Cancer Center
- Investigators
- Marco Mielcarek, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054353
- Sponsor's protocol ID
- 1743.00
- Other IDs
- NCI-2011-00386, 1743.00, P30CA015704
- Status last verified
- Sep 2017
- First submitted
- 5 Feb 2003
- Last updated
- 16 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial
- ClinicalTrials.gov ID
- NCT00054353
- Acronym / sponsor ID
- 1743.00
- Conditions
- Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- Primary completion
- Oct 2009 (actual)
- Study completion
- 14 Oct 2012 (actual)
- First posted
- 6 Feb 2003 (estimated)
- Results
- Posted 16 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the side effects of giving reduced-intensity conditioning followed by donor peripheral blood stem cell transplant (PBSCT) and how well it works in treating patients with multiple myeloma (MM). Giving low doses of chemotherapy, such as fludarabine phosphate and melphalan, and total-body irradiation (TBI) before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after transplant may stop this from happening.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of this approach by determining the 1-year progression-free survival (PFS) and overall survival (OS).
II. To evaluate day 100 non-relapse mortality.
III. To determine the incidences of grades II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or thrice daily (TID) on days 0-40 with taper to day 96 (unrelated donors).
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months, and then annually thereafter for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Related Donor | Experimental | Drug: fludarabine phosphate, Drug: melphalan, Radiation: total-body irradiation, Drug: mycophenolate mofetil, Drug: cyclosporine, Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantation, Other: laboratory biomarker analysisPREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). |
| Unrelated Donor | Experimental | Drug: fludarabine phosphate, Drug: melphalan, Radiation: total-body irradiation, Drug: mycophenolate mofetil, Drug: cyclosporine, Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantation, Other: laboratory biomarker analysisPREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meet Salmon and Durie criteria for initial diagnosis of MM; transplant will be offered to patients with previously treated MM who meet one of the following criteria:
- Patients must have the capacity to give informed consent
- DONOR: Human leukocyte antigen (HLA) genotypically identical sibling or phenotypically matched relative
- DONOR: HLA phenotypically matched unrelated donor (according to Standard Practice HLA matching criteria)
- DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for PBSC collection
Key exclusion criteria (29 listed)
- Karnofsky score < 60%
- Left ventricular ejection fraction < 40% or symptomatic heart failure; ejection fraction is required if age > 50 years or there is a history of anthracycline exposure or history of cardiac disease
- Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL,or symptomatic biliary disease
- Diffusion capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen
- Creatinine clearance < 40 mL/min
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 |
|---|---|---|
| fludarabine phosphateAlso: 2-F-ara-AMP, Beneflur, FludaraGiven IV | Drug | Related Donor, Unrelated Donor |
| melphalanAlso: Alkeran, CB-3025, L-PAM, L-phenylalanine mustardGiven IV | Drug | Related Donor, Unrelated Donor |
| total-body irradiationAlso: TBIUndergo TBI | Radiation | Related Donor, Unrelated Donor |
| mycophenolate mofetilAlso: Cellcept, MMFGiven PO | Drug | Related Donor, Unrelated Donor |
| cyclosporineAlso: ciclosporin, cyclosporin, cyclosporin A, CYSPGiven PO | Drug | Related Donor, Unrelated Donor |
| nonmyeloablative allogeneic hematopoietic stem cell transplantationUndergo reduced-intensity allogeneic PBSCT | Procedure or surgery | Related Donor, Unrelated Donor |
| peripheral blood stem cell transplantationAlso: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cellUndergo reduced-intensity allogeneic PBSCT | Procedure or surgery | Related Donor, Unrelated Donor |
| laboratory biomarker analysisCorrelative studies | Other | Related Donor, Unrelated Donor |
Primary outcome
PFS
Time frame: At 1 year post-transplant
PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas.
Non-relapse Mortality
Time frame: At day 100
Early NRM will be monitored in a sequential fashion.
Incidence of Acute GVHD (Grades III-IV)
Time frame: Up to 5 years
Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
Incidence of Chronic (Extensive) GVHD
Time frame: Up to 5 years
Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
4 secondary outcomes
OS
Time frame: At 6 months and then every year thereafter, up to 5 years
Engraftment
Time frame: Up to 5 years
Relapse Rate
Time frame: Up to 5 years
Response Rate
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marco Mielcarek principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fludarabine phosphate, melphalan and total-body irradiation in people with Refractory Multiple Myeloma, run by Fred Hutchinson Cancer Center at 2 sites in 2 countries.
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 29 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 16 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 2 sites in United States, Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 16 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?
PFS (time frame: At 1 year post-transplant). The study lists 4 primary outcomes in all. 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 16 Oct 2017.