NL-OMON54690招募中2 期
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (study 208887 DREAMM 5) - 208887 DREAMM5
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Males and females, age 18 years and above.
- •Histologically or cytologically confirmed multiple myeloma (MM).
- •Treated with at least 3 prior lines of prior anti-myeloma treatments
- •including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38
- •monoclonal antibody. See protocol section 5.1, item 3.
- •Eligibility in case of prior autologous stem cell transplant: transplant >
- •100 days before and no active infections.
- •ECOG performance status 0-1
- •Measurable disease. For further details: see protocol section 5.1, item 6.
- •Adequate organ function. For further details: see protocol section 5.1, item
- •Participants positive for Hepatitis B core antibody can het enrolled if the
- •following criteria are met:
- •- Serology results: HBcAb+, HBsAg-
- •- Screening: HBV DNA undetectable
- •- During Study Treatment: Monitoring per protocol, initiating
- •antiviral treatment if HBV DNA becomes detectable.
- •Participants who are currently receiving physiological doses oral steroids,
- •inhaled steroid or ophthalmalogical steroids are allowed on the study.
- •Males must agree to follow a required contraceptive method during the study
- •and during 6 months after the last dose of study medication (condom, even if
- •they have undergone vasectomy). For further details: see protocol section 5.1,
- •Not pregnant or breastfeeding females and females of non-reproductive
- •potential or reproductive potential and agrees to follow a required
- •contraceptive method during the study and during 4 months after the last dose
- •of study medication. For further details: see protocol section 5.1, item 9.
排除标准
- •Symptomatic amyloidosis, active POEMS syndrome, active plasma cell leukemia.
- •Corneal epithelial disease. For further details: see protocol section 5.2,
- •Current unstable liver or biliary disease per investigator assessment. For
- •further details: see protocol section 5.2, item 4.
- •Malignancy other than disease under study. For further details: see protocol
- •section 5.2, item 5.
- •Evidence of cardiovascular risk. For further details: see protocol section
- •5.2, item 6.
- •Active infection requiring systemic therapy, known HIV infection, positive
- •test for hepatitis B or hepatitis C. For further details: see protocol section
- •5.2, item 8-12.
- •Within the past 6 months: acute diverticulitis, inflammatory bowel disease,
- •intra-abdominal abscess, or gastrointestinal obstruction
- •Presence of active renal conditions (infection, requirement of dialysis or
- •any other condition that could affect participant's safety). Participants with
- •isolated proteinuria resulting from MM are eligible, provided they fulfill
- •criteria given in table 15 of the protocol.
- •Prior or concomitant therapies listed in protocol section 5.2, item 13-20.
- •Within 6 months: uncontrolled symptomatic ascites or pleural or pericardial
- •Life vaccine within 30 days of first dose of study medication. For further
- •details: see protocol section 5.2, item 23.
研究者
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