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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 272
- 试验地点
- 156
- 主要终点
- Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
研究概览
简要总结
The main aims of this 3-part study are as follows:
Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.
Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.
Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.
Participants will receive modakafusp alfa at one of two doses which will be given through a vein.
详细描述
The drug being tested in this study, and which will be given through a vein, is called modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The study will determine the safety, tolerability, and efficacy of modakafusp alfa as single agent and in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Parts:
Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension
The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in Part 3. Participants will be assigned to one of the following treatment groups in Parts 1 and 2 of the study. Participants will be randomly assigned in Part 3 of the study as given below:
- Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
- Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
- Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
- Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD
- Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg
- Part 3 (Dose Extension): Modakafusp alfa 120 mg
- Part 3 (Dose Extension): Modakafusp alfa 240 mg
The Part 1 (Dose Escalation) portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly up to 4 different schedules of administration of modakafusp alfa starting at 0.001 mg/kg for dose limiting toxicity (DLT) evaluation and to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for assessments in Part 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Parts 1 and 2:
- •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:
- •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.
- •For participants in Part 2 and 3 only: Measurable disease is defined as :
- •Serum M-protein ≥500 mg/dL (≥5 g/L)
- •Urine M-protein ≥200 mg/24 hours.
- •Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
- •During Part 1 only, 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.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
排除标准
- •For Parts 1 and 2:
- •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).
- •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.
- •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.
- •Has clinical signs of central nervous system involvement of MM.
- •For 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.
研究组 & 干预措施
Part 1 (Dose Escalation) Schedule A
Participants received Modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 1 (Dose Escalation) Schedule B
Participants received Modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 1 (Dose Escalation) Schedule C
Participants received Modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 1 (Dose Escalation) Schedule D
Participants received Modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
干预措施: Dexamethasone (Drug)
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
干预措施: Dexamethasone (Drug)
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Japan Lead-in: Modakafusp Alfa 60 mg
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
Japan Lead-in: Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
干预措施: Modakafusp alfa (Drug)
结局指标
主要结局
Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
时间窗: Up to 54.3 months in Part 1
Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.
Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 54.3 months in Part 1
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
时间窗: Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.
Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs
时间窗: Up to 54.3 months in Part 1
An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Percentages were rounded off to the nearest decimal.
Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)
时间窗: Up to approximately 54.3 months in Part 1
AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \& within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1)results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important event. Percentages were rounded off to nearest decimal.
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay
时间窗: Up to 54.3 months in Part 1
Percentages were rounded off to the nearest decimal.
Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE
时间窗: Up to 54.3 months in Part 1
An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions
时间窗: Up to 54.3 months in Part 1
Percentages were rounded off to the nearest decimal.
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions
时间窗: Up to 54.3 months in Part 1
Percentages were rounded off to the nearest decimal.
Part 1: Percentage of Participants With Clinically Significant Laboratory Values
时间窗: Up to 54.3 months in Part 1
Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.
Part 2: Overall Response Rate (ORR)
时间窗: Up to 34.7 months in Part 2
ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response \[sCR\] + complete response \[CR\] + very good partial response \[VGPR\] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)
时间窗: Up to 20.5 months in Part 3
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Scr: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.
次要结局
- Part 3: Objective Response Rate (ORR) by Investigator Assessment(Up to 20.5 months in Part 3)
- Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR(Up to 20.5 months in Part 3)
- Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2)
- Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa(Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa(Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa(Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa(Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa(Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa(Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: CL: Clearance for Modakafusp Alfa(Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C))
- Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3)
- Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa(Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C))
- Part 1: Overall Response Rate (ORR)(Up to 54.3 months in Part 1)
- Parts 1 and 2: Clinical Benefit Rate (CBR)(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2)
- Parts 1 and 2: Disease Control Rate (DCR)(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2)
- Parts 1, 2, and 3: Duration of Response (DOR)(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3)
- Parts 1 and 2: Time to Response(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2)
- Parts 2 and 3: Overall Survival (OS)(Up to 34.7 months in Part 2; Up to 20.5 months in Part 3)
- Parts 1, 2, and 3: Progression Free Survival (PFS)(Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3)
- Part 2: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: CL: Clearance for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: λz: Terminal Disposition Rate Constant for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: Vss: Volume of Distribution at Steady State for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa(Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D))
- Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator Assessment(Up to 20.5 months in Part 3)
- Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs)(Up to 20.5 months in Part 3)
- Part 3: Duration of Clinical Benefit(Up to 20.5 months in Part 3)
- Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment(Up to 20.5 months in Part 3)
- Part 3: Duration of Disease Control(Up to 20.5 months in Part 3)
- Part 3: Time to Progression (TTP) by IRC and Investigator Assessment(Up to 20.5 months in Part 3)
- Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR(Up to 20.5 months in Part 3)
- Part 3: Percentage of Participants With Treatment -Emergent Adverse Events (TEAEs)(Up to 20.5 months in Part 3)
- Part 3: Percentage of Participants With Clinically Significant Laboratory Values(Up to 20.5 months in Part 3)
- Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status(Up to 20.5 months in Part 3)
- Part 3: Health Care Utilization: Length of Hospital Stays(Up to 20.5 months in Part 3)
- Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit(Up to 20.5 months in Part 3)
- Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter(Up to 20.5 months in Part 3)
- Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)(Baseline, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months))