A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants With Newly Diagnosed Transplant Eligible Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 11
- 主要终点
- number of incidence and severity of adverse events [safety and tolerability]
研究概览
简要总结
A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma
OBJECTIVES:
To evaluate the safety and tolerability of teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM
To evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments; JNJ-79635322-based combinations as induction and as replacement for HDT+ASCT following induction; and teclistamab in combination with talquetamab
详细描述
OVERALL DESIGN:
160 participants will be enrolled with 10 participants in Arm A, 20 participants in Arm A1, 20 participants in Arm B, 10 participants in Arms C and 10 in C2, 20 participants in Arm D, 10 participants in each Arm E, E1 and optionally F and F, and 20 participants in Arm G. Cohorts may be further expanded.
Arms A, A1, B, D, E, E1, F, F1 will receive Induction therapy of 6 cycles (28-days each):
Treatment: Tec-DRd (Arm A, A1), Tec-DVRd (Arm B), Tal-DRd (Arms E, E1), Tal-DVRd (Arms F, F1) followed by HDT and a single ASCT according to local SoC treatment. Thereafter a Maintenance Therapy of maximum 18 cycles with either Tec-D (Arms A, A1, B, E, F) or Tal-D (E1, F1) is performed.
Arm D will receive 6 28-days cycles Tec-DVRd induction followed by 18 cycles Tec-Tal. Arm G will receive 6 28-day cycles of JNJ-79635322-DRd induction, followed by JNJ-79635322-D. No HDT ASCT will be performed in Arm D and Arm G.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 18 years of age to 70 years of age, inclusive
- •Have an ECOG performance status score of 0 to 2 at screening
- •Have an ECOG performance status score of 0 to 2 at screening and immediately prior to the start of administration of study treatment
- •Participants in Arms A, A1, B, D, E, E1, F, F1 and G must also satisfy all of the following criteria to be enrolled in the study:
- •1. Documented multiple myeloma requiring treatment as defined by the criteria below:
- •Multiple myeloma diagnosis according to the IMWG diagnostic criteria
- •Measurable disease at screening as defined by any of the following:
- •1. Serum M-protein level ≥1.0 g/dL or
- •Urine M-protein level ≥200 mg/24 hours or
- •Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio
- •Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan (except Arm D and G participants).
- •Participants Arm C and C2 must also satisfy all of the following criteria:
- •Newly diagnosed multiple myeloma according to IMWG criteria.
- •Must have received 4 to 6 28-day cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed
- •3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria for ≥PR based on repeat imaging utilizing the same modality
- •Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of enrollment.
排除标准
- •- CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
- •- Stroke or seizure within 6 months prior study start Cycle1 Day
- •- History of transplantations requiring immunosuppressive therapy.
- •- Seropositive for HIV, HEP B, Active Hep C infection (details see protocol).
- •- COPD with a FEV1 <50% of predicted normal.
- •- Moderate /severe persistent asthma within the past 2 years or any uncontrolled asthma. Exclude if FEV1 <50% of predicted normal.
- •- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures, or that in the investigators opinion would constitute a hazard for participants.
- •- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug/excipients.
- •- Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of any study treatment regimen.
- •- Plans to father a child while enrolled in this study or within 100 days after the last dose of any component of the study treatment regimen.
- •Arm A, A1, B, D, E, E1, F, F1
- •Prior or current systemic therapy or stem cell transplant for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
- •Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by the NCI-CTCAE Version
- •Due to a potential interaction with bortezomib, received a strong CYP3A4 inducer within 5 half-lives prior to enrollment
- •Arm C and C2
- •- Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
- •Progressed on multiple myeloma therapy at any time prior to screening.
- •Received a cumulative dose of corticosteroids equivalent to ≥40 mg of dexamethasone within the 14 day period before the start of study treatment administration.
- •Intolerant to the starting dose of lenalidomide (10 mg).
- •For further details on inclusion/exclusion criteria please refer to the study protocol.
研究组 & 干预措施
Arm B Tec-DVRd Induction and Tec-D Maintenance
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm A Tec-DRd Induction and Tec-D Maintenance
Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm A Tec-DRd Induction and Tec-D Maintenance
Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm A Tec-DRd Induction and Tec-D Maintenance
Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm A Tec-DRd Induction and Tec-D Maintenance
Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm B Tec-DVRd Induction and Tec-D Maintenance
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm B Tec-DVRd Induction and Tec-D Maintenance
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm B Tec-DVRd Induction and Tec-D Maintenance
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm B Tec-DVRd Induction and Tec-D Maintenance
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Bortezomib (Drug)
Arm C Tec-D Maintenance
Arm C participants will receive maximum 18 cycles of teclistamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm C Tec-D Maintenance
Arm C participants will receive maximum 18 cycles of teclistamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
干预措施: Daratumumab (Drug)
Arm A1 Tec-DRd Induction and Tec-D Maintenance
Arm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm A1 Tec-DRd Induction and Tec-D Maintenance
Arm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm A1 Tec-DRd Induction and Tec-D Maintenance
Arm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm C2 Tal-DR Maintenance
Arm C2 participants will receive maximum 18 cycles of talquetamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
干预措施: Daratumumab (Drug)
Arm C2 Tal-DR Maintenance
Arm C2 participants will receive maximum 18 cycles of talquetamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm C2 Tal-DR Maintenance
Arm C2 participants will receive maximum 18 cycles of talquetamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
干预措施: Talquetamab (Drug)
Arm D Tec-DRd Induction and Tec-Tal following induction
Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm D Tec-DRd Induction and Tec-Tal following induction
Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
干预措施: Daratumumab (Drug)
Arm D Tec-DRd Induction and Tec-Tal following induction
Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
干预措施: Dexamethasone (Drug)
Arm D Tec-DRd Induction and Tec-Tal following induction
Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
干预措施: Lenalidomide (Drug)
Arm D Tec-DRd Induction and Tec-Tal following induction
Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
干预措施: Talquetamab (Drug)
Arm E Tal-DRd Induction and Tec-D Maintenance
Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm E Tal-DRd Induction and Tec-D Maintenance
Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm E Tal-DRd Induction and Tec-D Maintenance
Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm E Tal-DRd Induction and Tec-D Maintenance
Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm E Tal-DRd Induction and Tec-D Maintenance
Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Talquetamab (Drug)
Arm E1 Tal-DRd Induction and Tal-D Maintenance
Arm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm E1 Tal-DRd Induction and Tal-D Maintenance
Arm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm E1 Tal-DRd Induction and Tal-D Maintenance
Arm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm E1 Tal-DRd Induction and Tal-D Maintenance
Arm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Talquetamab (Drug)
Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Teclistamab (Tec) (Drug)
Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Bortezomib (Drug)
Arm F Tal-DVRd Induction and Tec-D Maintenance
Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Talquetamab (Drug)
Arm F1 Tal-DVRd Induction and Tal-D Maintenance
Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Daratumumab (Drug)
Arm F1 Tal-DVRd Induction and Tal-D Maintenance
Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Dexamethasone (Drug)
Arm F1 Tal-DVRd Induction and Tal-D Maintenance
Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
Arm F1 Tal-DVRd Induction and Tal-D Maintenance
Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Bortezomib (Drug)
Arm F1 Tal-DVRd Induction and Tal-D Maintenance
Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Talquetamab (Drug)
Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following ind
Arm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.
干预措施: Daratumumab (Drug)
Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following ind
Arm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.
干预措施: Dexamethasone (Drug)
Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following ind
Arm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.
干预措施: Lenalidomide (Drug)
Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following ind
Arm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.
干预措施: JNJ-79635322 (Drug)
Arm A1 Tec-DRd Induction and Tec-D Maintenance
Arm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
number of incidence and severity of adverse events [safety and tolerability]
时间窗: through study completion, up to 28 months
次要结局
- MRD negativity rate(after 6 cycles (each cycle is 28 days) induction therapy (app.month 6), after High Dose Therapy (app. month 10), after 18 cycles (each cycle is 28 days) of maintenance therapy (app. month 28))
- Response on therapy [efficacy](after each cycle (each cycle is 28 days) induction ( app. at month 1,2,...,6), after High Dose therapy (app. month 10), after each cycle (each cycle is 28 days) of maintenance (app. at month 11,12, ...28), during FU every 3 months (app. up to 3-4 years))
- Progression Free Survival [efficacy](From randomization to the date of disease progression to death (app. up to 3-4 years))
- Serum concentration of teclistamab, talquetamab and daratumumab [pharmacokinetics](through study completion, up to 28 months)
- Presence of ADAs to teclistamab, talquetamab and daratumumab [immunogenicity](through study completion, up to 28 months)
- Stem cell yield(after High Dose Therapy (after app. 10 months))
- days to engraftment(after High Dose Therapy (after app. 10 months))
研究者
Marc Raab
Prof. Dr. med.
University of Heidelberg Medical Center