NL-OMON53729招募中3 期
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy - MonumenTAL-3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 25
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
- •- >=18 years of age.
- •- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis
- •according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •and b) Measurable disease at screening as defined by any of the following: i)
- •Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter
- •(g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg)/24
- •hours (central laboratory); iii) Light chain multiple myeloma without
- •measurable M-protein in the serum or the urine: serum immunoglobulin free light
- •chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal
- •serum immunoglobulin kappa lambda free light chain ratio
- •- Relapsed or refractory disease as defined by: i) Relapsed disease is defined
- •as an initial response to prior treatment, followed by confirmed progressive
- •disease by IMWG criteria greater than (>) 60 days after cessation of treatment;
- •ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in
- •monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG
- •criteria during previous treatment or less than or equal to (<=) 60 days after
- •cessation of treatment.
- •- Received at least 1 prior line of antimyeloma therapy including a proteasome
- •inhibitor (PI) and lenalidomide. Participants who have received only 1 prior
- •line of antimyeloma therapy must be considered lenalidomide-refractory (that
- •is, have demonstrated progressive disease by IMWG criteria on or within 60 days
- •of completion of lenalidomide-containing regimen). Participants who have
- •received >=2 prior lines of antimyeloma therapy must be considered lenalidomide
- •- Documented evidence of progressive disease based on investigator*s
- •determination of response by the IMWG criteria on or after their last regimen
- •- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of
- •0, 1, or 2 at screening and immediately prior to the start of administration of
- •study treatment
排除标准
- •- Contraindications or life-threatening allergies, hypersensitivity, or
- •intolerance to study drug excipients
- •- Disease is considered refractory to an anti-cluster of differentiation 38
- •(CD38) monoclonal antibody as defined per IMWG consensus guidelines
- •(progression during treatment or within 60 days of completing therapy with an
- •anti-CD38 monoclonal antibody)
- •- Received prior pomalidomide therapy
- •- A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of
- •prednisone or equivalent within 14-day period before the first dose of study
- •- Known active central nervous system (CNS) involvement or exhibits clinical
- •signs of meningeal involvement of multiple myeloma. If either is suspected,
- •negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are
- •- Plasma cell leukemia (per IMWG criteria) at the time of screening,
- •Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy,
- •M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain
- •amyloidosis
研究者
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