A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

Browse trials for

• Multiple Myeloma 3,627

Study arms

• Experimental
  JNJ-79635322

  Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity.

  Drug: JNJ-79635322

• Active comparator
  Anti BCMAxCD3 Bispecific Antibody

  Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity.

  Drug: Teclistamab

Interventions

• DrugJNJ-79635322

  JNJ-79635322 will be administered as SC injection.

• DrugTeclistamab

  Teclistamab will be administered as SC injection.

Primary outcomes

1. Overall Response

   Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.

   Time frame: Up to 5 years and 7 months

2. Progression-Free Survival (PFS)

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

   Time frame: Up to 5 years and 7 months

Secondary outcomes

1. Very Good Partial Response (VGPR) or Better

   VGPR or better is defined as achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the IMWG criteria during or after the study treatment but prior to subsequent antimyeloma therapy.

   Time frame: Up to 5 years and 7 months

2. Complete Response (CR) or Better

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

   Time frame: Up to 5 years and 7 months

3. Duration of Response (DoR)

   DoR is defined as the time interval between the date of initial documentation of a response (partial 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 and 7 months

4. Minimal Residual Disease (MRD)-negative CR

   MRD-negative CR is defined as the participants who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after the date of randomization and prior to PD or subsequent antimyeloma therapy. Additionally, participants must achieve CR or better, according to IMWG response criteria at any time from the date of randomization and within 3 months after achieving MRD negative status, prior to PD or subsequent antimyeloma therapy.

   Time frame: Up to 5 years and 7 months

5. MRD-Negative CR at 12 months

   MRD-negative CR at 12 months is defined as the participants who achieve MRD-negative status at the analysis time window of 12 months (+/-3 months) from the date of randomization, as determined by NGF prior to PD or subsequent anti-myeloma therapy. Additionally, participants must also achieve CR or better, according to IMWG criteria at any time from the date of randomization up to and including 12 months (+/-3 months), prior to PD or subsequent antimyeloma therapy.

   Time frame: 12 months

6. Sustained MRD-negative CR

   Sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGF, for at least 12 months without any examination showing MRD-positive status and prior to PD or subsequent anti-myeloma therapy.

   Time frame: Up to 5 years and 7 months

7. Progression-Free Survival on the First Subsequent Line of Antimyeloma 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 on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up.

   Time frame: Up to 5 years and 7 months

8. Overall Survival (OS)

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

   Time frame: Up to 5 years and 7 months

9. Time to Subsequent Anti-Myeloma Therapy

   Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.

   Time frame: Up to 5 years and 7 months

10. Number of Participants With Treatment-Emergent Adverse Events (TEAE) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event.

    Time frame: Up to 5 years and 7 months

11. Number of Participants with Abnormalities in Clinical Laboratories Results

    Number of participants with abnormalities in clinical laboratories results (serum chemistry and hematology) will be reported.

    Time frame: Up to 5 years and 7 months

12. Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Score

    Change from baseline in symptoms, functioning, and health-related quality of life (HRQoL) as assessed by multiple myeloma symptom and impact questionnaire (MySIm-Q) score will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM.

    Time frame: Baseline up to 5 years and 7 months

13. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Score

    Change from baseline in symptoms, functioning, and HRQoL as assessed by european organization for research and treatment of cancer quality of life questionnaire core 30 (EORTC-QLQ-C30) score will be reported.

    Time frame: Baseline up to 5 years and 7 months

14. Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Score

    The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

    Time frame: Baseline up to 5 years and 7 months

15. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score

    Time to worsening in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.

    Time frame: Up to 5 years and 7 months

16. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score

    Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Time frame: Up to 5 years and 7 months

17. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score

    The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

    Time frame: Up to 5 years and 7 months

18. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q Score

    The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. It is included to be 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: Up to 5 years and 7 months

19. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30 Score

    Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

    Time frame: Up to 5 years and 7 months

20. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L Score

    The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

    Time frame: Up to 5 years and 7 months

21. Percentage of Participants With Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 (EORTC IL46)

    Percentage of participants with side effects burden on the EORTC IL46 will be reported. The EORTC IL46 measures the global impression of burden due to treatment-related symptoms.

    Time frame: Up to 5 years and 7 months

22. Serum Concentrations for JNJ-79635322

    Serum concentrations of JNJ-79635322 will be reported.

    Time frame: Up to 5 years and 7 months

23. Number of Participants With Anti-drug Antibodies (ADA) to JNJ-79635322

    Serum samples will be analyzed for the detection of ADA to JNJ-79635322 using a validated assay method.

    Time frame: Up to 5 years and 7 months

24. Number of Participants With Neutralizing Antibodies (NAb) to JNJ-79635322

    Number of participants who are ADA-positive will be assessed for the presence of NAbs.

    Time frame: Up to 5 years and 7 months

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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