A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

Browse trials for

• Multiple Myeloma 3,626

Study arms

• Experimental
  Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)

  Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.

  Drug: Teclistamab · Drug: Daratumumab · Drug: Lenalidomide

• Experimental
  Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)

  Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.

  Drug: Daratumumab · Drug: Lenalidomide · Drug: Talquetamab

• Active comparator
  Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)

  Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

  Drug: Daratumumab · Drug: Lenalidomide · Drug: Dexamethasone

Interventions

• DrugTeclistamab

  Teclistamab will be administered as SC injection.

  Also known as: JNJ-64007957

• DrugDaratumumab

  Daratumumab will be administered as SC injection.

• DrugLenalidomide

  Lenalidomide will be administered orally.

• DrugDexamethasone

  Dexamethasone will be administered either orally or intravenously (IV).

• DrugTalquetamab

  Talquetamab will be administered as SC injection.

  Also known as: JNJ-64407564

Primary outcomes

1. Progression Free Survival (PFS)

   PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria.

   Time frame: From randomization to the date of disease progression or death (Up to 09 years)

2. 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)

   12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria.

   Time frame: At Month 12

Secondary outcomes

1. Very Good Partial Response (VGPR) or Better

   VGPR or better is defined as the percentage of participants achieving VGPR and CR (including stringent complete response \[sCR\]) prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.

   Time frame: From randomization up to 09 years

2. Complete Response (CR) or Better

   CR or better is defined as the percentage of participants achieving CR or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.

   Time frame: From randomization up to 09 years

3. Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)

   Sustained MRD-negative CR is defined as participants with CR or better who sustain MRD-negative status, as determined by NGS with sensitivity of 10\^-5, for at least 12 months without any examination showing MRD positive status or progressive disease in between.

   Time frame: From randomization up to 09 years

4. MRD-negative CR

   MRD-negative CR is defined as the percentage of participants who achieve MRD-negative status, as determined by NGS with sensitivity of 10\^-5, at any time after randomization and prior to progressive disease or subsequent antimyeloma therapy and who achieve CR or better.

   Time frame: From randomization up to 09 years

5. Progression Free Survival on Next-line Therapy (PFS2)

   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 that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.

   Time frame: From randomization up to 09 years

6. Overall Survival (OS)

   OS is defined as the time from the date of randomization to the date of death due to any cause.

   Time frame: From randomization to the date of death (up to 09 years)

7. Number of Participants with Adverse Events (AEs) by Severity

   An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

   Time frame: From randomization up to 09 years

8. Number of Participants with Abnormalities in Laboratory Parameters

   Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.

   Time frame: From randomization up to 09 years

9. Number of Participants with Abnormalities in Vital Signs

   Number of participants with abnormalities in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.

   Time frame: From randomization up to 09 years

10. Number of Participants with Abnormalities in Physical Examination

    Number of participants with abnormalities in physical examination will be reported.

    Time frame: From randomization up to 09 years

11. Number of Participants with Abnormalities in Electrocardiogram (ECG)

    Number of participants with abnormalities in ECG will be reported.

    Time frame: From randomization up to 09 years

12. Serum Concentrations of Teclistamab and Talquetamab

    Serum samples will be analyzed to determine concentrations of teclistamab and talquetamab using validated, specific, and sensitive methods.

    Time frame: From randomization up to 09 years

13. Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab

    Number of participants with ADAs to teclistamab and talquetamab will be reported.

    Time frame: From randomization up to 09 years

14. Change from Baseline in Symptoms, Functioning, and 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)

    The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days ("past week"), and 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: From baseline up to 9 years

15. Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common AEs 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 through Cycle 6 (each cycle of 28 days) (up to 196 days)

16. Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)

    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: From baseline up to 9 years

17. Time to Sustained Worsening in Symptoms, Functioning, and HRQoL

    Time to sustained worsening in symptoms, functioning and HRQoL is defined as the interval from the date of randomization to the start date of meaningful change.

    Time frame: From randomization up to 09 years

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu