Bristol-Myers Squibb: Myelodysplastic Syndromes trials

The registry lists 71 Myelodysplastic Syndromes studies with Bristol-Myers Squibb as lead sponsor. 4 are open to participants now and 20 have results posted.

Phase 1 18Phase 2 19Phase 3 12Phase 4 1No phase 26(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic NeoplasmsNot yet recruitingNCT07752121
• Asia Myelodysplastic Syndrome (MDS) RegistryRecruitingNCT07355478
• A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemiaRecruitingNCT06073860
• A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical TrialsRecruitingNCT04064060Phase 3
• A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic SyndromesTerminatedNCT05168202Phase 1Results posted
• An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell TransfusionCompletedNCT03900715Phase 2Results posted
• A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA NaïveActive, not recruitingNCT03682536Phase 3Results posted
• A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic SyndromesTerminatedNCT02848001Phase 1Results posted
• An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)CompletedNCT02775903Phase 2Results posted
• A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic SyndromesCompletedNCT02631070Phase 3Results posted
• Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic SyndromesCompletedNCT02281084Phase 2Results posted
• Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).CompletedNCT01835587Phase 1/2Results posted
• Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic SyndromeCompletedNCT01599325Phase 2Results posted
• The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)CompletedNCT01566695Phase 3Results posted
• Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)CompletedNCT01201811Phase 4Results posted
• An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)CompletedNCT01186939Phase 3Results posted
• Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003CompletedNCT01099267Results posted
• A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5qCompletedNCT01029262Phase 3Results posted
• A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic SyndromesCompletedNCT00910858Phase 1/2Results posted
• Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.CompletedNCT00812968Phase 2Results posted
• Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] AbnormalityCompletedNCT00179621Phase 3Results posted
• Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic SyndromesCompletedNCT00102687Phase 2Results posted
• A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional CareCompletedNCT00071799Phase 3Results posted
• Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic AbnormalityCompletedNCT00065156Phase 2Results posted
• A Study to Evaluate Luspatercept Utilization in Patients With Lower Risk Myelodysplastic Syndromes or Beta-thalassemiaTerminatedNCT07681440
• A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With LuspaterceptCompletedNCT07075406
• Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in ChinaCompletedNCT07073690
• Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In JapanCompletedNCT07008820
• A Study to Evaluate Treatment Patterns and Effectiveness of LuspaterceptCompletedNCT06971185
• A Study to Evaluate Luspatercept Treatment Patterns and Outcomes in Erythropoiesis-Stimulating Agents-Naïve Patients With Lower-Risk Myelodysplastic Syndromes in the United StatesCompletedNCT06851065
• A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic SyndromesWithdrawnNCT06581055
• Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic SyndromeTerminatedNCT06419634Phase 1
• A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome ParticipantsActive, not recruitingNCT06045689Phase 3
• ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood TransfusionsActive, not recruitingNCT05949684Phase 3
• A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)Active, not recruitingNCT05469737Phase 2/3
• A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)CompletedNCT05218902
• Study to Evaluate Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs)CompletedNCT04973280
• Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic SyndromesTerminatedNCT04951778Phase 1
• A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell TransfusionsCompletedNCT04477850Phase 2
• A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in KoreaCompletedNCT04036448
• Expanded Access for ACE-011No longer availableNCT03724227
• A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid TreatmentCompletedNCT02921815
• A Study of Special Use Results Surveillance of Revlimid 5mg CapsulesCompletedNCT02921802
• An Observational Post Authorisation Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the NetherlandsCompletedNCT02891551
• A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic NeoplasmsCompletedNCT02842229
• A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)TerminatedNCT02641002Phase 1
• Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)CompletedNCT02447666Phase 2
• Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)CompletedNCT02279654
• Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic MalignanciesCompletedNCT02223052Phase 1
• Validation of a Comprehensive Health Status Assessment Scale in Elderly Patients (≥ 65 Years) With Hematological MalignanciesCompletedNCT02164071
• Post Marketing Surveillance to Collect and Evaluate the Safety and Efficacy Information of Korean MDS Patients Treated With VIDAZA®, After Approval of Marketing Authorization for New Drug in KoreaCompletedNCT02137629
• Health Outcomes of Recently Diagnosed Myelodysplastic Syndrome (MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Depending on Treatment Strategy (Wait and See, Support, Active Treatment)CompletedNCT02085798
• Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDSCompletedNCT02018926Phase 1/2
• Phase 1 Study of CC-486 in Japanese Subjects With Hematological NeoplasmsTerminatedNCT01908387Phase 1
• Connect® Myeloid Disease RegistryTerminatedNCT01688011
• A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Patients With Myelodysplastic SyndromesCompletedNCT01571648Phase 1
• Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral AzacitidineCompletedNCT01519011Phase 1
• MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National RegistryCompletedNCT01347944
• Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple MyelomaCompletedNCT00761722Phase 1
• Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)TerminatedNCT00666497Phase 2
• Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous LeukemiaCompletedNCT00528983Phase 1
• AVIDA The Vidaza® (Azacitidine) Patient RegistryCompletedNCT00481273
• A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic SyndromesTerminatedNCT00458159Phase 1
• MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory DiseaseTerminatedNCT00374296Phase 2
• A Phase I/II Study of MGCD0103 With Azacitidine in Patients With High-Risk Myelodysplastic Syndrome (MDS) or Acute Myelogenous LeukemiaCompletedNCT00324220Phase 1/2
• A Phase I Study of MGCD0103 Given Twice Weekly in Patients With Leukemia or Myelodysplastic SyndromesCompletedNCT00324194Phase 1
• A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic SyndromesCompletedNCT00324129Phase 1
• Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic SyndromesCompletedNCT00064974Phase 2
• A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic SyndromesCompletedNCT00050843Phase 3
• Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic SyndromesCompletedNCT00045786Phase 2
• Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic SyndromeCompletedNCT00044382Phase 2