EUCTR2022-001442-38-PL进行中（未招募）1 期
A Phase 3 Study Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma who have Received at least 4 Prior Therapies Including an Immunomodulatory Drug, a Proteasome Inhibitor, and an Anti-CD38 Antibody - MonumenTAL-5
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
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
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. Be =18 years of age at the time of informed consent.
- •Disease Characteristics
- •2. Documented multiple myeloma as defined by the criteria below:
- •a. Multiple myeloma according to IMWG diagnostic criteria.
- •b. Measurable disease at screening, as assessed by central laboratory, defined by any of the following:
- •1) Serum M-protein level =1.0 g/dL; or
- •2) Urine M-protein level =200 mg/24 hours; or
- •3) Light chain multiple myeloma without measurable M-protein in the serum or the urine: sFLC =10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda FLC ratio.
- •Prior Therapy Restrictions or Requirements
- •3. Received at least 4 prior antimyeloma therapies including an anti-CD38 mAb (alone or in combination) and is refractory per IMWG criteria to at least one PI, and one IMiD.
- •4. Documented evidence of progressive disease based on investigator’s determination of response by IMWG criteria on or after their last regimen.
- •Performance Status
- •5. Have an ECOG performance status of 0 to 2 at screening.
- •Clinical Laboratory Values
- •6. Have clinical laboratory values meeting the criteria during the Screening Phase.
- •7. Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
- •? No detectable viral load (ie, <50 copies/mL) at screening
- •? CD4+ count >300 cells/mm^3 at screening
- •? No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
- •? Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening. Note: HAART that could interfere with study treatment is excluded (consult the sponsor for a review of medications prior to enrollment).
- •Sex and Contraceptive/Barrier Requirements
- •8. A female participant of childbearing potential must have a negative serum pregnancy testat screening, and must agree to further serum or urine pregnancy tests during the study and within 6 months after receiving the last dose of study treatment.
- •9. A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or for 6 months after the last dose of study treatment.
- •10. A female participant must be either of the following:
- •a. Not of childbearing potential, or
- •b. Of childbearing potential and
- •1) Practicing true abstinence; or
- •2) Have a sole partner who is bilaterally vasectomized; or
- •3) Practicing at least 1 highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and
- •agrees to remain on a highly effective method while receiving study treatment and until 6 months after the last dose of study treatment. The investigator must evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •11. A female participant using oral contraceptives must use an additional barrier contraceptive method.
- •12. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment as anticancer treatments may impair fertility.
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •Medical Conditions
- •1. Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- •2. Stroke or seizure within 6 months prior to signing ICF.
- •3. Presence of the following cardiac conditions:
- •a. New York Heart Association Stage III or IV congestive heart failure.
- •b. Myocardial infarction or coronary artery bypass graft =6 months prior to randomization.
- •c. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.
- •d. History of severe non-ischemic cardiomyopathy.
- •4. Any of the following:
- •a. Hepatitis B infection (hepatitis B surface antigen or HBV-DNA positive): In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.
- •b. Active hepatitis C infection as measured by positive HCV-RNA testing.
- •Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection
- •(defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the participant is eligible for the study.
- •5. Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
- •6. Current corneal epithelial disease except mild punctate keratopathy.
- •7. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:
- •a. Uncontrolled diabetes
- •b. Acute diffuse infiltrative pulmonary disease.
- •c. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy.
- •d. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. EXCEPTION: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed.
- •e. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status.
- •f. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •g. History of noncompliance with recommended medical treatments.
- •Disease Characteristics
- •8. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- •9. Plasma cell leukemia (>2.0×10^9/L) at the time of screening, Waldenström's macroglobulinemia, POEMS syndrom
研究者
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