A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
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1. Progression-Free Survival (PFS) (Time Frame - Up to 6 years 6 months): PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.
Secondary outcome:
1. Overall Response (Partial Response [PR] or Better) (Time Frame - Up to 6 years 6 months): Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.
2. Very Good Partial Response (VGPR) or Better Rate (Time Frame - Up to 6 years 6 months): VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.
3. Complete Response (CR) or Better Rate (Time Frame - Up to 6 years 6 months): CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.
4. Overall Minimal Residual Disease (MRD) Negative CR (Time Frame - Up to 6 years 6 months): MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.
5. Overall Survival (OS) (Time Frame - Up to 6 years 6 months): OS is defined as the time from the date of randomization to the date of the participant's death.
6. Progression-free Survival on Next-line Therapy (PFS2) (Time Frame - Up to 6 years 6 months): PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
7. Time to Next Therapy (TTNT) (Time Frame - Up to 6 years 6 months): TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.
8. Number of Participants with Adverse Events (AEs) (Time Frame - Up to 6 years 6 months): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
9. Number of Participants with AEs by Severity (Time Frame - Up to 6 years 6 months): Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
10. Serum Concentrations of Talquetamab (Time Frame - Up to 6 years 6 months): Serum concentrations of talquetamab will be reported.
11. Serum Concentrations of Daratumumab (Time Frame - Up to 6 years 6 months): Serum concentrations of daratumumab will be reported.
12. Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab (Time Frame - Up to 6 years 6 months): Number of participants with presence ADAs to talquetamab will be reported.
13. Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab (Time Frame - Up to 6 years 6 months): Number of participants with presence of ADAs to daratumumab will be reported.
14. Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) (Time Frame - Up to 6 years 6 months): The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).
15. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c (Time Frame - Up to 6 years 6 months): The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.
16. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 (Time Frame - Up to 6 years 6 months): Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.
17. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE (Time Frame - Up to 6 years 6 months): The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.
18. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) (Time Frame - Up to 6 years 6 months): The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.
19. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) (Time Frame - Up to 6 years 6 months): The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.
20. Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) (Time Frame - Baseline up to 6 years 6 months): The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.
21. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c (Time Frame - Baseline up to 6 years 6 months): The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.
22. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 (Time Frame - Baseline up to 6 years 6 months): Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.
23. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE (Time Frame - Baseline up to 6 years 6 months): The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.
24. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) (Time Frame - Baseline up to 6 years 6 months): The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.
25. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) (Time Frame - Baseline up to 6 years 6 months): The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.
Experimental: Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP) Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Experimental: Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Experimental: Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D) Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Talquetamab (JNJ-64407564): Talquetamab will be administered subcutaneously.
Daratumumab: Daratumumab will be administered subcutaneously.
Pomalidomide: Pomalidomide will be administered orally.
Dexamethasone: Dexamethasone will be administered orally or intravenously.
Quelle: ClinicalTrials.gov
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"A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment"
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