A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Overview
- Phase
- Phase 3
- Intervention
- Isatuximab SC
- Conditions
- Plasma Cell Myeloma Recurrent
- Sponsor
- Sanofi
- Enrollment
- 531
- Locations
- 146
- Primary Endpoint
- Overall Response Rate (ORR)
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms:
Arm SC: Isatuximab SC + Pd
Arm IV: Isatuximab IV + Pd
Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Detailed Description
Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
- •Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)).
Exclusion Criteria
- •Primary refractory multiple myeloma participants
- •Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
- •Prior therapy with pomalidomide
- •Participants with inadequate biological tests.
- •Significant cardiac dysfunction
- •Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
- •Concomitant plasma cell leukemia
- •Active primary amyloid light -chain amyloidosis
- •Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
- •Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
Arms & Interventions
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Isatuximab SC
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Dexamethasone
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Pomalidomide
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Montelukast
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Paracetamol / Acetaminophen
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Diphenhydramine
Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Methylprednisolone
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Isatuximab IV
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Dexamethasone
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Pomalidomide
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Montelukast
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Paracetamol / Acetaminophen
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Diphenhydramine
Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Intervention: Methylprednisolone
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months
ORR by independent review committee (IRC) using 2016 international myeloma working group (IMWG) criteria:Percentage of participants with complete response (CR),stringent CR (sCR),very good partial response (VGPR) \& partial response (PR).CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas (STP),\<5% plasma cells in bone marrow (BM) aspirates \& a normal free light chain(FLC)ratio (0.26-1.65).sCR:CR plus no clonal cells in BM biopsy. VGPR:serum \& urine M-protein detectable by immunofixation, not electrophoresis;\>=90% reduction in serum M-protein plus urine M-protein level\<100mg/24hour(h);\>=90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in STP;FLC only:\>=90% decrease in difference between involved and uninvolved FLC levels.PR:\>=50% reduction of serum M-protein and reduction in 24h urine M-protein by \>=90% or to \<200mg/24h.In addition to above, if present at baseline,\>=50% reduction in size SPD of STPs also required.
Observed Concentration Before Dosing (Ctrough) of Isatuximab at Steady State
Time Frame: Pre-dose at Cycle 6 Day 1
Ctrough at steady state was the observed plasma concentration collected on pre-dose at Cycle 6 Day 1 (equivalent to prior to Cycle 6 Day 1) of isatuximab administration dose.
Secondary Outcomes
- Ctrough of Isatuximab at 4 Weeks (CT4W)(Pre-dose at Cycle 2 Day 1 (at 4 weeks))
- Percentage of Participants With Infusion Reactions(From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 28 months)
- Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15(Cycle 5 Day 15)
- Time to First Response (TT1R)(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Very Good Partial Response or Better Rate(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Duration of Response (DOR)(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Progression Free Survival (PFS)(From first dose of study medication administration (Day 1) up to a maximum of 57 months)
- Overall Survival (OS)(From first dose of study medication administration (Day 1) up to a maximum of 57 months)
- Time to Best Response (TTBR)(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Progression Free Survival 2 (PFS2)(From first dose of study medication administration (Day 1) up to a maximum of 57 months)
- Ctrough of Isatuximab(Pre-dose on Cycle 1 Days 8, 15 and 22, Cycles 2 to 5 Days 1 and 15, Cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 and 27 Day 1)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months)
- Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)(From first dose of study medication administration (Day 1) up to 30 days after the last dose of study medication, approximately 28 months)
- Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Percentage of Participants With Response to 'Patient Expectation Questionnaire at Baseline (PEQ-BL)'(Baseline (Cycle 1 Day 1))
- Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ(From Cycle 2 Day 1 up to EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 6 to 29 Day 15)
- Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'(Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 29 Day 15)
- Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'(EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- HRUPQ: Baseline Healthcare Utilization: Number of Nights in the Past 6 Months a Participant Stayed in Hospital(Baseline (Cycle 1 Day 1))
- Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire(EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care(Baseline (Cycle 1 Day 1))
- HRUPQ: Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Consulted a Healthcare Professional (HCP)(Baseline (Cycle 1 Day 1))
- Percentage of Participants Who Retired Early Due to MM Based on HRUPQ(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ(Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Percentage of Participants Who Ever Retired During the Study Based on HRUPQ(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)
- Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Role Functioning(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Physical Functioning(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Emotional Functioning(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Cognitive Functioning(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Social Functioning(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Fatigue(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Pain(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Dyspnea(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Insomnia(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Appetite Loss(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Constipation(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Diarrhea(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-C30: Financial Difficulties(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-MY20: Future Perspective(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in EORTC QLQ-MY20: Body Image(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)(Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months))
- ORR Based on at Least 1 Chromosomal Abnormality(From first dose of study medication administration (Day 1) up to PCD (06-Nov-2024), approximately 28 months)