ISRCTN80324107进行中（未招募）3 期
A Phase III randomized study comparing teclistamab monotherapy versus pomalidomide, bortezomib, dexamethasone (PVd) or carfilzomib, dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 590
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
- 性别
- All
入选标准
- •1. Documented diagnosis of multiple myeloma as defined by the criteria below:
- •1.1. Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria.
- •1.2. Measurable disease at screening as defined by any of the following:
- •1.2.1. Serum M-protein level =0.5 grams per deciliter (g/dL) (central laboratory)
- •1.2.2. Urine M-protein level =200 milligrams (mg)/24 hours (central laboratory)
- •1.2.3. Serum immunoglobulin free light chain =10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •2. Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti-cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line.
- •3. Documented evidence of progressive disease or failure to achieve a response to the last line of therapy based on the investigator’s determination of response by International myeloma working group (IMWG) criteria.
- •4. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
- •5. A female participant must agree not to be pregnant, breastfeeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
- •6. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
排除标准
- •1. Received any prior B cell maturation antigen (BCMA)-directed therapy
- •2. A participant is not eligible to receive PVd as control therapy if any of the following are present:
- •2.1. Received prior pomalidomide therapy,
- •2.2. Does not meet criteria for bortezomib retreatment,
- •2.3. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib,
- •2.4. Grade 1 peripheral neuropathy with pain or Grade =2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0,
- •2.5. Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomisation
- •3. A participant is not eligible to receive Kd as control therapy if any of the following are present:
- •3.1. Received prior carfilzomib therapy,
- •3.2. Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment,
- •3.3. Grade 2 peripheral neuropathy with pain or Grade =3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0,
- •3.4. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
- •4. Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
- •5. Received a live, attenuated vaccine within 4 weeks before randomisation
- •6. Plasma cell leukaemia at the time of screening, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
- •7. Received a maximum cumulative dose of corticosteroids of =140 mg of prednisone or equivalent within 14 days prior to randomisation
研究者
相似试验
进行中（未招募）
3 期
A Study of Teclistamab in Combination with Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab and Lenalidomide (Tal-DR) in Participants with Newly Diagnosed Multiple MyelomaCancerMultiple MyelomaISRCTN72661732Janssen-Cilag International NV1,030
进行中（未招募）
1 期
A randomized phase 3 study of Teclistamab in combination with daratumumab verses an Investigators choice of Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Velcade, Dexamethasone in Relapsed or Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple MyelomaEUCTR2020-004742-11-DEJanssen-Cilag International NV578
招募中
1 期
A randomized phase 3 study of teclistamab in combination with daratumumab and lenalidomide; talquetamab in combination with daratumumab and lenalidomide; versus a combination of daratumumab, lenalidomide and dexamethasone in new multiple myeloma patients who cannot undergo stem cell transplant as the first therapy.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple MyelomaEUCTR2022-000909-28-NLJanssen-Cilag International NV1,590
进行中（未招募）
1 期
A randomized phase 3 study of teclistamab in combination with daratumumab and lenalidomide; talquetamab in combination with daratumumab and lenalidomide; versus a combination of daratumumab, lenalidomide and dexamethasone in new multiple myeloma patients who cannot undergo stem cell transplant as the first therapy.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple MyelomaEUCTR2022-000909-28-DKJanssen-Cilag International NV1,590
招募中
3 期
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial TherapyMultiple MyelomaNL-OMON56272Janssen-Cilag30