Multiple MyelomaPhase 2NCT02416206
High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
A Phase 2 study testing BeEAM in people with Multiple Myeloma, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. 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?
- BeEAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2015to 21 Apr 2021
- 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
- Age between 18 - 70 years
- Karnofsky status ≥ 70%
- Diagnosis of Multiple Myeloma
- Within 9 months of the start of induction chemotherapy and no evidence of relapse or progression.
- Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least 2x106/kg.
Who cannot join
- Poor cardiac function: left ventricular ejection fraction <40%
- Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted
- Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT > 3X ULN
- Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min (calculated creatinine clearance is permitted)
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
- Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
About this study
Official title: A Phase II Trial of High-dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Up-front Treatment of Multiple Myeloma
High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. Following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results to single-agent Melphalan with higher toxicity.
Read the detailed description
Myeloma patients, following up-front induction therapy, will receive an ASCT following a high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as results from our institution, suggests that following ASCT for the upfront treatment of myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that under this protocol, this rate will be at least 65%. Thus we statistically formalize this study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
- Conditions
- Multiple Myeloma
- Being tested
- BeEAM
- Keywords
- Multiple myeloma, hematopoietic stem cell transplant
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeEAMDrug
BeEAM
| Study group | Role | What they receive |
|---|---|---|
| BeEAM | Experimental | Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma Receives: Drug: BeEAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Estimate the Response at Day 100 Following Transplant (Rate of CR)
Using IMWG criteria: PR (partial response) noted as >50% reduction of serum M-protein and reduction in 24hr urinary M-protein by >90% or to <200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >90% reduction in serum M-protein plus urine M-protein level <100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Measured: Day 100
Secondary outcomes (3)
Number of Patients With Overall Survival Post-transplant
Measured: 3 years
Number of Patients With Progression-free Survival
Measured: 3 years
Number of Patients Who Relapsed After Transplant
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study start27 Apr 2015
- Primary completion26 Mar 2020
- Study completion21 Apr 2021
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 (26)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Scott R Solomon, MD, Principal investigator, Northside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416206
- Sponsor's protocol ID
- NSH 1107
- Status last verified
- May 2023
- First submitted
- 11 Mar 2015
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Attal M, Harousseau JL. The role of high-dose therapy with autologous stem cell support in the era of novel agents. Semin Hematol. 2009 Apr;46(2):127-32. doi: 10.1053/j.seminhematol.2009.02.006.
PubMed 19389496Harousseau JL, Attal M, Divine M, Marit G, Leblond V, Stoppa AM, Bourhis JH, Caillot D, Boasson M, Abgrall JF, et al. Autologous stem cell transplantation after first remission induction treatment in multiple myeloma. A report of the French Registry on Autologous Transplantation in Multiple Myeloma. Stem Cells. 1995 Aug;13 Suppl 2:132-9. doi: 10.1002/stem.5530130721.
PubMed 8520502Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
PubMed 8649495Harousseau JL, Avet-Loiseau H, Attal M, Charbonnel C, Garban F, Hulin C, Michallet M, Facon T, Garderet L, Marit G, Ketterer N, Lamy T, Voillat L, Guilhot F, Doyen C, Mathiot C, Moreau P. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 Trials. J Clin Oncol. 2009 Dec 1;27(34):5720-6. doi: 10.1200/JCO.2008.21.1060. Epub 2009 Oct 13.
PubMed 19826130Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009 Jan;23(1):3-9. doi: 10.1038/leu.2008.291. Epub 2008 Oct 30.
PubMed 18971951Alexanian R, Weber D, Giralt S, Dimopoulos M, Delasalle K, Smith T, Champlin R. Impact of complete remission with intensive therapy in patients with responsive multiple myeloma. Bone Marrow Transplant. 2001 May;27(10):1037-43. doi: 10.1038/sj.bmt.1703035.
PubMed 11438818Alvares CL, Davies FE, Horton C, Patel G, Powles R, Sirohi B, Zuha R, Gatt A, Saso R, Treleaven JG, Dearden CE, Potter MN, Ethell ME, Morgan GJ. Long-term outcomes of previously untreated myeloma patients: responses to induction chemotherapy and high-dose melphalan incorporated within a risk stratification model can help to direct the use of novel treatments. Br J Haematol. 2005 Jun;129(5):607-14. doi: 10.1111/j.1365-2141.2005.05514.x.
PubMed 15916682Bjorkstrand B, Goldstone AH, Ljungman P, Brandt L, Brunet S, Carlson K, Prentice G, Cavo M, Samson D, de Laurenzi A, et al. Prognostic factors in autologous stem cell transplantation for multiple myeloma: an EBMT Registry Study. European Group for Bone Marrow Transplantation. Leuk Lymphoma. 1994 Oct;15(3-4):265-72. doi: 10.3109/10428199409049723.
PubMed 7866274Krejci M, Buchler T, Hajek R, Svobodnik A, Krivanova A, Pour L, Adam Z, Mayer J, Vorlicek J. Prognostic factors for survival after autologous transplantation: a single centre experience in 133 multiple myeloma patients. Bone Marrow Transplant. 2005 Jan;35(2):159-64. doi: 10.1038/sj.bmt.1704728.
PubMed 15543200O'Shea D, Giles C, Terpos E, Perz J, Politou M, Sana V, Naresh K, Lampert I, Samson D, Narat S, Kanfer E, Olavarria E, Apperley JF, Rahemtulla A. Predictive factors for survival in myeloma patients who undergo autologous stem cell transplantation: a single-centre experience in 211 patients. Bone Marrow Transplant. 2006 Apr;37(8):731-7. doi: 10.1038/sj.bmt.1705307.
PubMed 16501593Giralt S, Vesole DH, Somlo G, Krishnan A, Stadtmauer E, Mccarthy P, Pasquini MC; Blood and Marrow Transplant Clinical Trials Network Multiple Myeloma Working Group. Re: Tandem vs single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysis. J Natl Cancer Inst. 2009 Jul 1;101(13):964; author reply 966-7. doi: 10.1093/jnci/djp126. Epub 2009 Jun 17. No abstract available.
PubMed 19535777Harousseau JL, Moreau P. Evolving role of stem cell transplantation in multiple myeloma. Clin Lymphoma Myeloma. 2005 Sep;6(2):89-95. doi: 10.3816/CLM.2005.n.034.
PubMed 16231846Lahuerta JJ, Grande C, Martinez-Lopez J, De La Serna J, Toscano R, Ortiz MC, Larregla S, Conde E, Insunza A, Gonzalez-San Miguel JD, Bargay J, Cabrera R, Garcia-Ruiz JC, Albo C, Garcia-Alonso L, Solano F, Vivancos P, Leon A, San Miguel J; Grupo Espanol de Sindromes Linfoproliferativos/Trasplante Autologo de Medula Osea. Tandem transplants with different high-dose regimens improve the complete remission rates in multiple myeloma. Results of a Grupo Espanol de Sindromes Linfoproliferativos/Trasplante Autologo de Medula Osea phase II trial. Br J Haematol. 2003 Jan;120(2):296-303. doi: 10.1046/j.1365-2141.2003.04067.x.
PubMed 12542490Anagnostopoulos A, Aleman A, Ayers G, Donato M, Champlin R, Weber D, Alexanian R, Giralt S. Comparison of high-dose melphalan with a more intensive regimen of thiotepa, busulfan, and cyclophosphamide for patients with multiple myeloma. Cancer. 2004 Jun 15;100(12):2607-12. doi: 10.1002/cncr.20294.
PubMed 15197803Brinker BT, Waller EK, Leong T, Heffner LT Jr, Redei I, Langston AA, Lonial S. Maintenance therapy with thalidomide improves overall survival after autologous hematopoietic progenitor cell transplantation for multiple myeloma. Cancer. 2006 May 15;106(10):2171-80. doi: 10.1002/cncr.21852.
PubMed 16598756
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of High-dose Bendamustine, Etoposide, Cytarabine, and Melphalan (BeEAM) in the Up-front Treatment of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02416206
- Acronym / sponsor ID
- NSH 1107
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, hematopoietic stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Northside Hospital, Inc.University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. Following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results to single-agent Melphalan with higher toxicity.
Detailed description
Myeloma patients, following up-front induction therapy, will receive an ASCT following a high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as results from our institution, suggests that following ASCT for the upfront treatment of myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that under this protocol, this rate will be at least 65%. Thus we statistically formalize this study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BeEAM | Experimental | Drug: BeEAMBendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 - 70 years
- Karnofsky status ≥ 70%
- Diagnosis of Multiple Myeloma
- Within 9 months of the start of induction chemotherapy and no evidence of relapse or progression.
- Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least 2x106/kg.
Key exclusion criteria (7 listed)
- Poor cardiac function: left ventricular ejection fraction <40%
- Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted
- Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT > 3X ULN
- Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min (calculated creatinine clearance is permitted)
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
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 |
|---|---|---|
| BeEAMBeEAM | Drug | BeEAM |
Primary outcome
To Estimate the Response at Day 100 Following Transplant (Rate of CR)
Time frame: Day 100
Using IMWG criteria: PR (partial response) noted as >50% reduction of serum M-protein and reduction in 24hr urinary M-protein by >90% or to <200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >90% reduction in serum M-protein plus urine M-protein level <100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
3 secondary outcomes
Number of Patients With Overall Survival Post-transplant
Time frame: 3 years
Number of Patients With Progression-free Survival
Time frame: 3 years
Number of Patients Who Relapsed After Transplant
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19389496Attal M, Harousseau JL. The role of high-dose therapy with autologous stem cell support in the era of novel agents. Semin Hematol. 2009 Apr;46(2):127-32. doi: 10.1053/j.seminhematol.2009.02.006.
- Background: PubMed 8520502Harousseau JL, Attal M, Divine M, Marit G, Leblond V, Stoppa AM, Bourhis JH, Caillot D, Boasson M, Abgrall JF, et al. Autologous stem cell transplantation after first remission induction treatment in multiple myeloma. A report of the French Registry on Autologous Transplantation in Multiple Myeloma. Stem Cells. 1995 Aug;13 Suppl 2:132-9. doi: 10.1002/stem.5530130721.
- Background: PubMed 8649495Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
- Background: PubMed 19826130Harousseau JL, Avet-Loiseau H, Attal M, Charbonnel C, Garban F, Hulin C, Michallet M, Facon T, Garderet L, Marit G, Ketterer N, Lamy T, Voillat L, Guilhot F, Doyen C, Mathiot C, Moreau P. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 Trials. J Clin Oncol. 2009 Dec 1;27(34):5720-6. doi: 10.1200/JCO.2008.21.1060. Epub 2009 Oct 13.
- Background: PubMed 18971951Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009 Jan;23(1):3-9. doi: 10.1038/leu.2008.291. Epub 2008 Oct 30.
- Background: PubMed 11438818Alexanian R, Weber D, Giralt S, Dimopoulos M, Delasalle K, Smith T, Champlin R. Impact of complete remission with intensive therapy in patients with responsive multiple myeloma. Bone Marrow Transplant. 2001 May;27(10):1037-43. doi: 10.1038/sj.bmt.1703035.
- Background: PubMed 15916682Alvares CL, Davies FE, Horton C, Patel G, Powles R, Sirohi B, Zuha R, Gatt A, Saso R, Treleaven JG, Dearden CE, Potter MN, Ethell ME, Morgan GJ. Long-term outcomes of previously untreated myeloma patients: responses to induction chemotherapy and high-dose melphalan incorporated within a risk stratification model can help to direct the use of novel treatments. Br J Haematol. 2005 Jun;129(5):607-14. doi: 10.1111/j.1365-2141.2005.05514.x.
- Background: PubMed 7866274Bjorkstrand B, Goldstone AH, Ljungman P, Brandt L, Brunet S, Carlson K, Prentice G, Cavo M, Samson D, de Laurenzi A, et al. Prognostic factors in autologous stem cell transplantation for multiple myeloma: an EBMT Registry Study. European Group for Bone Marrow Transplantation. Leuk Lymphoma. 1994 Oct;15(3-4):265-72. doi: 10.3109/10428199409049723.
- Background: PubMed 15543200Krejci M, Buchler T, Hajek R, Svobodnik A, Krivanova A, Pour L, Adam Z, Mayer J, Vorlicek J. Prognostic factors for survival after autologous transplantation: a single centre experience in 133 multiple myeloma patients. Bone Marrow Transplant. 2005 Jan;35(2):159-64. doi: 10.1038/sj.bmt.1704728.
- Background: PubMed 16501593O'Shea D, Giles C, Terpos E, Perz J, Politou M, Sana V, Naresh K, Lampert I, Samson D, Narat S, Kanfer E, Olavarria E, Apperley JF, Rahemtulla A. Predictive factors for survival in myeloma patients who undergo autologous stem cell transplantation: a single-centre experience in 211 patients. Bone Marrow Transplant. 2006 Apr;37(8):731-7. doi: 10.1038/sj.bmt.1705307.
- Background: PubMed 19535777Giralt S, Vesole DH, Somlo G, Krishnan A, Stadtmauer E, Mccarthy P, Pasquini MC; Blood and Marrow Transplant Clinical Trials Network Multiple Myeloma Working Group. Re: Tandem vs single autologous hematopoietic cell transplantation for the treatment of multiple myeloma: a systematic review and meta-analysis. J Natl Cancer Inst. 2009 Jul 1;101(13):964; author reply 966-7. doi: 10.1093/jnci/djp126. Epub 2009 Jun 17. No abstract available.
- Background: PubMed 16231846Harousseau JL, Moreau P. Evolving role of stem cell transplantation in multiple myeloma. Clin Lymphoma Myeloma. 2005 Sep;6(2):89-95. doi: 10.3816/CLM.2005.n.034.
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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.
Scott R Solomon, MD principal investigator
Northside Hospital
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 BeEAM in people with Multiple Myeloma, run by Northside Hospital, Inc. 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 5 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 18 May 2023. 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 18 May 2023). 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?
To Estimate the Response at Day 100 Following Transplant (Rate of CR) (time frame: Day 100). 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 NCT02416206, which also lists 26 linked publications.
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 18 May 2023.