JPRN-jRCT2061220078进行中（未招募）1 期
A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma
Asato Takayuki0 个研究点目标入组 336 人开始时间: 2022年12月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •For Parts 1 and 2, and Japan Safety Lead-in:
- •1.Has MM defined by the IMWG criteria with evidence of disease progression and:
- •- In need of additional myeloma therapy as determined by the investigator.
- •- Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug [IMiD], a proteasome inhibitor [PI], an alkylating agent, and/or an anti-CD38 as single agents or in combination).
- •- Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD.
- •For Part 3:
- •1.Has MM defined by the IMWG criteria with evidence of disease progression and:
- •- In need of additional myeloma therapy as determined by the investigator.
- •- Has previously received at least 3 lines of myeloma therapy.
- •- Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible.
- •2.For participants in Part 2 and 3 only: Measurable disease is defined as:
- •a.Serum M-protein >= 500 mg/dL (>= 5 g/L)
- •b.Urine M-protein >= 200 mg/24 hours.
- •c.Serum free light chain (FLC) assay, with involved FLC level >=10 mg/dL (>=100 mg/L) provided serum FLC ratio is abnormal.
- •3.During Part 1 and Japan Safety Lead-in, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to [>=] 10 percent [%]) and/or plasmacytoma (>=1 centimeter [cm] in diameter) detected by physical examination or imaging.
- •4.Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.
排除标准
- •1.Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
- •2.Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
- •3.Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (=<) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to =< Grade 2 or baseline.
- •4.Has clinical signs of central nervous system involvement of MM.
- •For Japan Safety Lead-in and Part 3:
- •-Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded.
- •-In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
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