EUCTR2020-004533-21-FR进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF PF-06863135 MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Age and Sex:
- •1. Male or female participants age =18 years.
- •Type of Participant and Disease Characteristics:
- •2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •3. Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014).
- •4. Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- •a. Serum M-protein >0.5 g/dL by SPEP
- •b. Urinary M-protein excretion >200 mg/24 hours by UPEP
- •c. Serum immunoglobulin FLC=10 mg/dL (=100 mg/L) AND abnormal serum
- •immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
- •5. Refractory to at least one IMiD.
- •6. Refractory to at least one PI.
- •7. Refractory to at least one anti-CD38 antibody.
- •8. Relapsed/refractory to last anti-MM regimen.
- •Note: Refractory is defined as having disease progression while on therapy or within
- •60 days of last dose in any line, regardless of response.
- •9. Cohort A: Has not received prior BCMA-directed therapy.
- •Cohort B: Has received prior BCMA-directed ADC or BCMA-directed CAR T-cell
- •therapy, either approved or investigational.
- •10. ECOG performance status =2.
- •11. LVEF =40% as determined by a MUGA scan or ECHO.
- •12. Adequate hepatic function characterized by the following:
- •a. Total bilirubin =2 x ULN (=3 x ULN if documented Gilbert’s syndrome);
- •b. AST =2.5 x ULN; and
- •c. ALT =2.5 x ULN
- •13. Adequate renal function defined by an estimated creatinine clearance =30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
- •14. Adequate BM function characterized by the following:
- •a. ANC =1.0 × 10^9/L;
- •b. Platelets =25 × 10^9/L; and
- •c. Hemoglobin =8 g/dL
- •15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1
- •Informed Consent:
- •16. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions:
- •1. Smoldering MM.
- •2. Active Plasma cell leukemia.
- •3. amyloidosis.
- •4. Active GVHD.
- •5. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:
- •a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
- •b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
- •c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack,
- •cerebrovascular accident, deep vein thrombosis or pulmonary embolism);
- •d. Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
- •6. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
- •7. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- •8. Other surgical, medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Prior/Concomitant Therapy:
- •9. Previous treatment with an anti-BCMA bispecific antibody.
- •Prior/Concurrent Clinical Study Experience:
- •10. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Other Exclusions:
- •11. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
研究者
相似试验
进行中（未招募）
2 期
MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAbrelapsed/refractory multiple myelomaJPRN-jRCT2031210228Kawai Norisuke150
进行中（未招募）
1 期
AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF PF-06863135 MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODYMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864MULTIPLE MYELOMAEUCTR2020-004533-21-ESPfizer Inc.150
招募中
2 期
A Study to Evaluate Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC)2023-503629-20-00F. Hoffmann-La Roche AG50
进行中（未招募）
1 期
A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Triple-Negative Breast Cancer (MORPHEUS-TNBC)EUCTR2017-002038-21-ESF. Hoffman-La Roche Ltd.110
招募中
2 期
A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)2023-504038-23-00F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG149