NCT03242889已完成1 期
A Phase 1 Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 5
- 主要终点
- Number of Participants With Adverse Events Including Dose Limiting Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant proven to have Multiple Myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •Participant must have measurable, secretory disease as defined by any of the following:
- •Immunoglobulin (Ig) G MM: serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >= 200 milligram (mg)/24 hours; or
- •IgA, IgD, IgE MM: serum M-protein level >= 0.5 g/dL or urine M-protein level >= 200 mg/24 hours; or
- •Light chain MM, for participants without measurable disease in the serum or urine: serum Ig free light chains (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
- •Participant must have received >= 2 prior lines of antimyeloma therapy without further established treatment option
- •Participant must have relapsed or refractory disease
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •The Participant must meet the following criteria of clinical laboratory test results during screening phase:
- •hemoglobin >=7.5 g/dL (>=5 millimoles/liter [mmol/L]) (without prior Red Blood Cells (RBC) transfusion within 7 days before the laboratory test;
- •absolute neutrophil count (ANC) >=1.0*10^9/L (without granulocyte colony stimulating factor support in the 7 days prior the laboratory test);
- •platelet count >=75*10^9/L for participants in whom less than (<)50.0 percent (%) of bone marrow nucleated cells are plasma cells; otherwise platelet count >=50*10^9/L (without transfusion support in the 7 days prior to the laboratory test);
- •aspartate aminotransferase (AST) less than or equal to (<=)3.0 times upper limit of normal (ULN);
- •alanine aminotransferase (ALT) <=3.0 times ULN;
- •creatinine clearance >20 mL/minute/1.73 m^2;
- •total bilirubin <=2.0 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 times ULN is required);
- •corrected serum calcium <=14 mg/dL (<=3.5 mmol/L)
- •Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use highly effective methods of reliable birth control. Contraception must begin 4 weeks before initiating treatment, during therapy, during dose interruptions, and continue for 6 months following discontinuation of study therapy
- •A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control, even if he had a successful vasectomy, for example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 6 months after receiving the final dose of study drug
排除标准
- •Participant has received daratumumab or other anti cluster of differentiation (CD)38 therapies previously
- •Participant has received antimyeloma treatment within 2 weeks before Cycle 1 Day 1
- •Participant has received autologous stem cell transplantation (ASCT) within 12 weeks before Cycle 1 Day 1, or the participant has previously received an allogenic stem cell transplant (regardless of timing)
- •Participant has received a cumulative dose of corticosteroids equivalent or more than the equivalent of 140 mg of prednisolone within the 2-week period before Cycle 1 Day 1
- •Participant has a history of malignancy (other than MM) within 3 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
研究组 & 干预措施
DARA SC
Experimental
Participants will receive DARA SC (daratumumab 1800 milligram [mg] with Recombinant Human Hyaluronidase [rHuPH20] 30,000 units [U] that is 2000 U/milliliter [U/mL]) subcutaneous (SC) injection once weekly for the first 8 weeks in Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks in Cycles 3 to 6 (Days 1 and 15) for the following 16 weeks and then every 4 weeks (from Cycle 7 [Day 1]) in subsequent cycles until disease progression, unacceptable toxicity, or any other reason for discontinuation. Each cycle is 28 days in duration.
干预措施: DARA SC (Drug)
结局指标
主要结局
Number of Participants With Adverse Events Including Dose Limiting Toxicity
时间窗: Up to 30 days after last study drug dose (approximately up to 1 year)
An adverse event (AE) is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
次要结局
- Maximum Observed Concentration (Cmax) of Daratumumab(Up to 8 weeks after the last dose of study drug (approximately up to 1 year))
- Maximum Serum Trough Concentration (Ctrough) of Daratumumab(At Cycle 3 Day 1 predose concentration)
- Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies(Up to 8 weeks after the last dose of study drug (approximately up to 1 year))
- Overall Response Rate(Approximately up to 1 year)
- Duration of Response (DOR)(First documentation of confirmed PR or better to the date of first documented progressive disease (PD), or date of death due to PD, whichever occurs first (approximately up to 1 year))
- Time to Response(Approximately up to 1 year)
研究者
研究点 (5)
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