Daratumumab
DrugDaratumumab will be administered SC injection.
NCT Number: NCT05083169
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daratumumab will be administered SC injection.
Pomalidomide will be administered orally.
Dexamethasone will be administered orally or intravenously.
Bortezomib will be administered SC injection.
Teclistamab will be administered SC injection.
Other names: JNJ-64007957
Time frame: 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.
Time frame: Up to 5 years
Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria.
Time frame: Up to 5 years
VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria.
Time frame: Up to 5 years
CR or better is defined as participants who achieve a CR or better response per IMWG criteria.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
OS is measured from the date of randomization to the date of the participant's death.
Time frame: Up to 5 years
TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment.
Time frame: 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.
Time frame: Up to 5 years
Number of participants with AEs by Severity will be reported.
Time frame: Up to 5 years
Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method.
Time frame: Up to 5 years
Number of participants with ADAs to teclistamab and daratumumab will be reported.
Time frame: Up to 5 years
Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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."
Time frame: Up to 5 years
PFS in participants with high-risk molecular features will be reported.
Time frame: Up to 5 years
Depth of response in participants in high-risk molecular features will be reported.
Janssen Research & Development, LLC
Industry
A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
Acronym: MajesTEC-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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