A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory 多发性骨髓瘤
关于
This study is researching an experimental drug called linvoseltamab, also called REGN5458.
Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. 在那个研究中, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), 包括一些有完整回答的参与者(即, the treatment got rid of all evidence of myeloma in their bodies).
This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, 波马度胺和地塞米松, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, 一种蛋白体抑制剂, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.
This study is looking at several other research questions, including:
- How long participants benefit from receiving linvoseltamab compared with EPd
- How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much
- What side effects happen from taking linvoseltamab compared to EPd
- How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd
- If there is any improvement in pain after treatment with linvoseltamab compared to EPd
资格
主要入选标准:
- Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. 疼痛)在与医学监督员讨论后可以被允许.
- Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, 如协议所述. Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, 包括CD38抗体.
- Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, 如协议所述
- 足够的血液, 肝, 肾功能和心功能, 还有足够的骨髓储备的证据
- 预期寿命至少6个月
主要排除标准:
- 浆细胞白血病的诊断, 淀粉样变, Waldenstrom巨球蛋白血, 或POEMS综合征(多发性神经病), organomegaly, 内分泌病, 单克隆蛋白, 皮肤变化).
- 既往接受过依妥珠单抗和/或泊马度胺治疗
- Participants with known MM brain lesions or meningeal involvement
- 治疗 with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, 以较短的为准
- History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
- Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
- 进行性多灶性脑白质病(PML)病史, 已知或怀疑PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder.
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
- 不受控制的人类免疫缺陷病毒(HIV)感染, hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, 在协议中定义.
NOTE: Other protocol defined inclusion/exclusion criteria apply
加入这个试验
- 皇冠hga025大学洛杉矶分校韦斯特伍德