Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
Interventions
DRUGJNJ-79635322
JNJ-79635322 will be administered as SC injection.
DRUGTeclistamab
Teclistamab will be administered as 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 diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory * Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation (CD) 38 antibody and lenalidomide * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2 at screening and immediately before the first dose of study medication * Have clinical laboratory values meeting the criteria specified in the protocol during the screening and within 1 day of the start of administration of study treatment
Exclusion criteria
* Major surgery, (for example, requiring general anesthesia) or significant traumatic injury within 2 weeks prior to first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients * Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM); ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy; iii. Any active malignancy (that is, progressing or requiring treatment change in the last 24 months) other than MM * Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) or Better | Up to approximately 41 months | CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment. |
| Progression-Free Survival (PFS) | Up to approximately 41 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores | Up to approximately 41 months | Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. |
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores | Up to approximately 41 months | 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. |
| Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46 | Up to approximately 41 months | The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale. |
| Overall Response Rate (ORR) | Up to approximately 41 months | ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria. |
| Very Good Partial Response (VGPR) or Better | Up to approximately 41 months | VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment. |
| Duration of Response (DoR) | Up to approximately 41 months | DoR is defined as the time interval between 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. |
| Minimal Residual Disease (MRD)-negative CR | Up to approximately 41 months | MRD-negative CR is defined as the percentage of participants with CR or better who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy. |
| MRD-negative CR at 1 Year | At 1 Year | MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria. |
| MRD-negative CR at 5 Years | At 5 Years | MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria. |
| Progression-Free Survival on the First Subsequent Line of Antimyeloma Therapy (PFS2) | Up to approximately 41 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. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up. |
| Overall Survival (OS) | Up to approximately 41 months | OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. |
| Time To Next Line of Therapy (TTNT) | Up to approximately 41 months | TTNT 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. |
| Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity | Up to approximately 41 months | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. 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 will be considered treatment-related regardless of the start date of the event. 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, Grade 5= death related to adverse event. |
| Number of Participants with Abnormalities in Laboratory Parameters | Up to approximately 41 months | Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported. |
| Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores | From Baseline up to approximately 41 months | Change from baseline in HRQoL, symptoms and functioning as assessed by 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. |
| Change from Baseline in HRQoL, Symptoms and Functioning Using the European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Scores | From Baseline up to approximately 41 months | Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported. |
| Change from Baseline in HRQoL, Symptoms and Functioning Using the European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores | From Baseline up to approximately 41 months | 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 to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores | Up to approximately 41 months | Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM. |
| Time to Worsening in HRQoL, Symptoms and Functioning using the EQ-5D-5L Scale Scores | Up to approximately 41 months | 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 to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores | Up to approximately 41 months | Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported. |
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores | Up to approximately 41 months | The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed