Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Talquetamab + Pomalidomide (Tal-P): Participants will receive talquetamab as subcutaneous (SC) injections - 28 days as per cycle
dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Intervention2: Talquetamab + Teclistamab (Tal-Tec): Participants will receive teclistamab in combination
dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Control Intervention1: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexametha
or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally 21 day cycle as per investigator choice. Dexamethasone will be administered as a pretreatment medication.
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: -Documented multiple myeloma as defined by the criteria below: a. multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria b. measurable disease at screening as assessed by central laboratory, defined by any of the following: (i) serum M-protein level greater than or equal to greater than equal to 0.5 gram per deciliter; or (ii) urine M-protein level greater than equal 200 milligram (mg) per 24 hours; or (iii) light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain (FLC) greater than equal 10 milligrams per deciliter and abnormal serum Ig kappa lambda FLC ratio -Relapsed or refractory disease as defined below: a) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than 60 days after cessation of treatment. b) Refractory disease is defined as less than 25 percent reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or less than or equal to 60 days after cessation of treatment - Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen- Have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment -A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment
Exclusion criteria
Exclusion criteria: - Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients - Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF) - Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment - A maximum cumulative dose of corticosteroids of greater than equal 140 mg of prednisone or equivalent within 14-day period before the first dose of study drug - Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS)Timepoint: Up to 7 years 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30Timepoint: Up to 7 years 2 months;Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste SurveyChange from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste SurveyTimepoint: Up to 7 years 2 months;Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EQ-5D-5LTimepoint: Up to 7 years 2 months;Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by MySIm-QTimepoint: Up to 7 years 2 months;Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by PGI-STimepoint: Up to 7 years 2 months;Complete Response (CR) or Better RateTimepoint: Up to 7 years 2 months;Minimal Residual Disease (MRD)-negative CR RateTimepoint: Up to 7 years 2 months;Number of Participants with Anti-drug Antibodies (ADAs) to Talquetamab and TeclistamabTimepoint: Up to 7 years 2 months;Overall Response Rate (ORR)Timepoint: Up to 7 years 2 months;Overall Survival (OS)Timepoint: Up to 7 years 2 months;Percentage of Participants With Meaningful Improvement in HRQoL as Assessed by EORTC-QLQ-C30Timepoint: Up to 7 years 2 months;Progression Free Survival on Next-line Therapy (PFS2)Timepoint: Up to 7 years 2 months;Serum Concentration of Talquetamab and TeclistamabTimepoint: p to 7 years 2 months;Time to Next Treatment (TTNT)Timepoint: Up to 7 years 2 months;Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30Timepoint: Up to 7 years 2 months;Time to Sustained Worsening in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Epstein Taste SurveyTimepoint: Up to 7 years 2 months;Time to Sustained Worsening in Symptoms, Functioning, a | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Poland, Republic of Korea, Saudi Arabia, Spain, Sweden, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Sanish Davis
Janssen Pharmaceutical Companies of Johnson and Johnson Pvt Ltd.
Outcome results
None listed