Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
Interventions
DRUGDaratumumab
Daratumumab will be administered SC injection.
DRUGPomalidomide
Pomalidomide will be administered orally.
DRUGDexamethasone
Dexamethasone will be administered orally or intravenously.
DRUGBortezomib
Bortezomib will be administered SC injection.
DRUGTeclistamab
Teclistamab will be administered SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion * Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment * Have clinical laboratory values within the specified range
Exclusion criteria
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Up to 5 years | PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) or Better | Up to 5 years | CR or better is defined as participants who achieve a CR or better response per IMWG criteria. |
| Minimal Residual Disease (MRD)-negativity | Up to 5 years | MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy. |
| Progression Free Survival on Next-line Therapy (PFS2) | Up to 5 years | 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. |
| Overall Survival (OS) | Up to 5 years | OS is measured from the date of randomization to the date of the participant's death. |
| Time to Next Treatment (TTNT) | Up to 5 years | TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment. |
| Duration of Response | Up to 5 years | Duration of response will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria, or death due to any cause, whichever occurs first. |
| Number of Participants with Adverse Events (AEs) by Severity | Up to 5 years | Number of participants with AEs by Severity will be reported. |
| Serum Concentration of Teclistamab | Up to 5 years | Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method. |
| Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab | Up to 5 years | Number of participants with ADAs to teclistamab and daratumumab will be reported. |
| Time to Worsening of Symptoms | Up to 5 years | Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change. |
| Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) | Baseline up to 5 years | The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Overall Response (Partial Response [PR] or Better) | Up to 5 years | Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria. |
| Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score | Baseline up to 5 years | The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale. |
| Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c) | Baseline up to 5 years | The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. Higher overall score indicates more sleep disturbance. |
| Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ) | Baseline up to 6 months | The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact. |
| Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) | Baseline up to 5 years | The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) | Baseline up to 5 years | The PGIS contains 2 questions on how the participant would currently rate severity of symptoms and impacts with a 7-day recall period. The response options are presented as a 5-point verbal rating scale from 1="none" to 5="very severe." |
| PFS in Participants with High-risk Molecular Features | Up to 5 years | PFS in participants with high-risk molecular features will be reported. |
| Very Good Partial Response (VGPR) or Better | Up to 5 years | VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria. |
| Depth of Response in Participants in High-risk Molecular Features | Up to 5 years | Depth of response in participants in high-risk molecular features will be reported. |
Countries
Argentina, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed