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
- Conditions
- Multiple MyelomaCancer
- Registration Number
- ISRCTN72661732
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1030
Current inclusion criteria as of 03/01/2024:
1. Sex: All
2. Gender-Based: No
3. Aged 18 years old and over
4. Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
5. Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
7. A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
8. A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
_____
Previous inclusion criteria from 14/09/2023 to 03/01/2024:
1. Sex: All
2. Gender-Based: No
3. Aged 18 years old and over
4. Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
5. Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
7. A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
8. A participant must agree not to plan to father a child while enrolled in this study or within 3 months after the last dose of study treatment.
_____
Previous inclusion criteria:
1. Sex: All
2. Gender-Based: No
3. Aged 18 years old and over
4. Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
5. Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to:
5.1. Advanced age OR
5.2. Presence of comorbid condition(s) likely to have a negative impact on the tolerability of high-dose chemotherapy with ASCT OR
5.3. Deferral of high-dose chemotherapy with ASCT as initial treatment
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
7. A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment
8. A male participant must agree not to plan to father a child while enrolled in this study or within 3 months after the last dose of study treatment
Current exclusion criteria as of 14/09/2023:
1. Received any prior therapy for multiple myeloma or smouldering myeloma other than a short course of corticosteroids (not to exceed 40 milligrams [mg] of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of dexamethasone during the Screening Phase
2. Had plasmapheresis within 28 days of randomisation
3. Had a stroke, transient ischaemic attack, or seizure within 6 months prior to randomisation
4. Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
5. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
6. Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone
____
Previous exclusion criteria:
1. Received a cumulative dose of systemic corticosteroids equivalent to greater than or equal to (>=) 20 milligrams (mg) of dexamethasone within 14 days before randomisation
2. Had plasmapheresis within 28 days of randomisation
3. Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomisation
4. Known allergies, hypersensitivity, or intolerance to teclistamab excipients
5. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method