A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma - TRIMM-2

Janssen-Cilag0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•- Documented initial diagnosis of multiple myeloma according to International
•Myeloma Working Group (IMWG) diagnostic criteria
•- Must have either of the following: a) received at least 3 prior lines of
•therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2
•cycles or 2 months of
•treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of
•treatment) in any order during the treatment or b) disease that is double
•refractory to a PI
•and an IMiD
•- Measurable disease at screening as defined by any of the following: Serum
•monoclonal protein (M-protein) level >=1.0 grams per deciliter (g/dL) (in non-
•immunoglobulin
•G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200
•milligrams (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin
•free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum
•Ig kappa lambda FLC ratio
•- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
•at screening and at Cycle 1, Day 1 predose
•- Female participants of childbearing potential must have a negative
•highly-sensitive serum beta*human chorionic gonadotropin (beta-hCG) pregnancy
•test (less than [<] 5
•international units per milliliter [IU/mL]) at screening and a negative urine
•or serum pregnancy test within 1 day before the first dose of study drug

•- Treatment in the prior 3 months with an anti- cluster of differentiation 38
•(CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38
•therapy at any time due to an adverse event related to the anti-CD38 therapy -
•Live, attenuated vaccine within 4 weeks prior to the first
•dose of study drug unless approved by sponsor
•- Active Central nervous system involvement or exhibits clinical signs of
•meningeal involvement of multiple myeloma. If either is suspected, brain
•resonance imaging (MRI) and lumbar cytology are required
•- Seropositive for hepatitis B (defined by a positive test for hepatitis B
•surface antigen [HBsAg]). Participants with resolved infection must be screened
•using real-time
•polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV)
•deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
•- Active hepatitis C infection as measured by positive hepatitis C virus-
•ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C
•virus antibody
•positivity must undergo HCV-RNA testing

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