Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: JNJ-79635322: Participants will receive JNJ-79635322 as an injection under the skin (Subcutaneous). Treatment will be of a finite duration or intolerable toxicity (whichever is earlier)
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Documented diagnosis of multiple myeloma as defined by the criteria below: a. MM diagnosis according to the international myeloma working group diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory 2 Received 1 to 3 prior lines of antimyeloma therapy, including an anti-cluster of differentiation 38 antibody and lenalidomide 3 Have an eastern cooperative oncology group performance status of 0 to 2 at screening and immediately before the first dose of study medication 4 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
Exclusion criteria: 1 Major surgery 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 2 Suspected or known allergies, hypersensitivity, intolerance or other contraindications to the use of JNJ-79635322 or teclistamab or their excipients 3 Presence of any of the following i. Any ongoing myelodysplastic syndrome or B-cell malignancy, ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy, iii. Any active malignancy other than MM 4 Known active or prior central nervous system involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging and lumbar cytology are required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response or Better -is defined as the percentage of participants achieving CR or stringent complete response prior to subsequent antimyeloma therapy in accordance with the international myeloma working group criteria during or after the study treatment. Progression-Free Survival 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 Timepoint: Up to approximately 41 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores 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 to 100 . The scores for the 5 dimensions are used to compute a single utility score, ranging from zero to 1, representing the general health status of the individual.Timepoint: Up to approximately 41 months;Percentage of Participants who Report Side Effects Burden on the European Organization for Research and Treatment of Cancer Item List 46 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 scaleTimepoint: Up to approximately 41 months;Overall Response Rate ORR is defined as the percentage of participants who achieve partial response or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.Timepoint: Up to approximately 41 months;Very Good Partial Response or Better 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.Timepoint: Up to approximately 41 months;Duration of Response DoR is defined as the time interval between the date of initial documentation of a response 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.Timepoint: Up to approximately 41 months;Minimal Residual Disease-negative CR 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 cytometr | — |
Countries
Australia, Brazil, Canada, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Poland, Republic of Korea, Spain, Taiwan, Turkey, United States of America
Contacts
Public ContactDr Rajesh Naik
Johnson and Johnson Private Limited
Outcome results
None listed