CTRI/2024/03/064587尚未招募1 期
A Phase 1, Randomized, Dose and Schedule Evaluation Study toInvestigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity ofBelantamab Mafodotin Administered in Combination with Standard of Care inParticipants with Newly Diagnosed Multiple Myeloma - DREAMM-9
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Participant must be over 18 years of age inclusive, at the time of signing the informed
- •Type of Participant and Disease Characteristics
- •2. Diagnosis of multiple myeloma with a requirement for treatment as documented per
- •International Myeloma Working Group (IMWG) criteria [Rajkumar, 2014].
- •a. Urine M-protein excretion =200 mg/24 hrs (=0.2g/24 hrs), or
- •b. Serum M-protein concentration =0.5 g/dL (=5.0 g/L), or
- •c. Serum free light chain (FLC) assay: involved FLC level =10 mg/dL
- •(=100 mg/L) and an abnormal serum free light chain ratio ( <0.26 or >1.65).
- •3. Not a candidate for high-dose chemotherapy with ASCT due to presence of
- •significant comorbid condition(s), such as cardiac, pulmonary or other major organ
- •dysfunction that are likely to have a negative impact on tolerability of high dose
- •chemotherapy with stem cell transplantation, as judged by the investigator. The
- •reason(s) for transplant ineligibility will be collected in the case report forms (CRFs).
- •4. ECOG status of 0-2.
- •5. Adequate organ system functions as defined by the laboratory assessments listed in
- •6. Sex and Contraception/Barrier Requirements
- •Female Participants
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and
- •at least 1 of the following conditions applies:
- •Is NOT a woman of childbearing potential (WOCBP) as defined in Section 10.4.
- •Due to lenalidomide being a thalidomide analogue with risk for embryo fetal
- •toxicity and prescribed under a pregnancy prevention/controlled distribution
- •program, and bortezomib having the potential to cause fetal harm, WOCBP
- •participants will be eligible if they commit to either:
- •abstain continuously from heterosexual sexual intercourse as their preferred
- •and usual lifestyle (abstinent on a long term and persistent basis) and agree to
- •remain abstinent
- •to use birth control as follows:
- •Two methods of reliable birth control (one method that is highly effective
- •and one additional effective (barrier) method), beginning 4 weeks prior to
- •initiating treatment with lenalidomide, during therapy, during dose
- •interruptions and continuing for 4 weeks following discontinuation of
- •lenalidomide treatment.
- •Thereafter, WOCBP participants must use one method of reliable birth
- •control that is highly effective for a total of 4 months following
- •discontinuation of belantamab mafodotin, or a total of 7 months following
- •discontinuation of bortezomib, whichever is longer.
- •Male Participants:
- •Contraceptive use by men should be consistent with local regulations regarding the
- •methods of contraception for those participating in clinical studies.
- •Male participants are eligible to participate if they agree to the following from the time of
- •first dose of study treatment until 28-days after the last dose of lenalidomide, 4-months
- •after the last dose of bortezomib, or 6 months after the last dose of belantamab
- •mafodotin, whichever is longer, to allow for clearance of any altered sperm:
- •Refrain from donating sperm
- •PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
- •(abstinent on a long
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Type of Participant and Disease Characteristics
- •1. Smoldering multiple myeloma (SMM).
- •2. Prior systemic therapy for multiple myeloma, or SMM.
- •3. Participant is eligible for high dose chemotherapy with ASCT, as determined by a
- •frailty score of 0 as assessed by the IMWG frailty index.
- •Medical Conditions
- •4. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCICTCAE
- •Version 5.
- •5. Major surgery within 4 weeks prior to the first dose of study drug.
- •6. Presence of active renal condition (infection, requirement for dialysis or any other
- •significant condition that could affect participant’s safety). Participants with isolated
- •proteinuria resulting from MM are eligible, provided they fulfil criteria given in Table7.
- •7. Any serious and/or unstable pre-existing medical, psychiatric disorder or other
- •conditions (including lab abnormalities) that could interfere with participant’s safety,
- •obtaining informed consent or compliance to the study procedures.
- •8. Evidence of active mucosal or internal bleeding uncontrolled by local therapy and not
- •explained by reversible coagulopathy.
- •9. Current active liver or biliary disease (except for Gilbert’s syndrome or asymptomatic
- •gallstones, or otherwise stable chronic liver disease as per the Investigator’s
- •assessment).
- •10. Participants with previous or concurrent malignancies other than multiple myeloma
- •are excluded. Exceptions are surgically treated cervical carcinoma in situ, or any
- •other malignancy that has been considered medically stable for at least 2 years. The
- •participant must not be receiving active therapy, other than hormonal therapy for this
- •disease. Note: Participants with curatively treated non-melanoma skin cancer are allowed
- •without a 2-year restriction.
- •11. Evidence of cardiovascular risk including any of the following:
- •a. Evidence of current clinically significant untreated arrhythmias, including
- •clinically significant ECG abnormalities including second degree (Mobitz Type
- •II) or third degree atrioventricular (AV) block.
- •b. History of myocardial infarction, acute coronary syndromes (including unstable
- •angina), coronary angioplasty, or stenting or bypass grafting within 3 months of
- •c. Class III or IV heart failure as defined by the New York Heart Association
- •functional classification system (Section 10.8).
- •d. Uncontrolled hypertension.
- •12. Active infection requiring treatment.
- •13. Known HIV infection.
- •14. Presence of Hepatitis B surface antigen (HBsAg), or Hepatitis B core antibody
- •(HBcAb), at screening or within 3 months prior to first dose of study treatment.
- •15. Positive Hepatitis C antibody test result or positive Hepatitis C RNA test result at
- •screening or within 3 months prior to first dose of study treatment unless the
- •participant can meet the following criteria:
- •a. RNA test negative
- •b. Successful anti-viral treatment (usually 8 weeks duration) is required, followed by
- •a negative HCV RNA test after a washout period of at least 4 weeks upon completion of anti-viral treatment.
- •16. Current corneal epithelial disease except for mild punctate k
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