|
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
RECRUITINGPhase 3Sponsored by Janssen Research & Development, LLC
Actively Recruiting
PhasePhase 3
SponsorJanssen Research & Development, LLC
Started2022-10-25
Est. completion2031-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations63 sites
View on ClinicalTrials.gov →
NCT05552222
Summary
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria * 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 * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * 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 * 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 Exclusion Criteria: * Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization * Had plasmapheresis within 28 days of randomization * Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization * Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients * Known contraindications to the use of daratumumab or lenalidomide per local prescribing information * Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
Conditions2
CancerMultiple Myeloma
Interventions5
Locations63 sites
Banner MD Anderson Cancer Center
UCSF Fresno
City of Hope Duarte
City of Hope Orange County Lennar Foundation Cancer Center
Find trials near these locations
Cancer trials in TucsonCancer trials in Los AngelesCancer trials in OrlandoCancer trials in ChicagoCancer trials in LouisvilleCancer trials in BaltimoreCancer trials in OmahaCancer trials in New YorkCancer trials in CharlotteCancer trials in ClevelandCancer trials in ColumbusCancer trials in NashvilleAll trials in ArizonaAll trials in CaliforniaAll trials in FloridaAll trials in GeorgiaAll trials in IllinoisAll trials in KentuckyAll trials in LouisianaAll trials in MarylandAll trials in NebraskaAll trials in New MexicoAll trials in New YorkAll trials in North CarolinaAll trials in OhioAll trials in PennsylvaniaAll trials in TennesseeAll trials in TexasAll trials in VirginiaAll trials in Washington
Related trials
- A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03) — Nanjing IASO Biotechnology Co., Ltd.
- A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma — Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma — Janssen Research & Development, LLC
- A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant — Pfizer
- A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant — European Myeloma Network B.V.
- Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients — North Estonia Medical Centre
- Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma — Canadian Cancer Trials Group
- GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 — University of Heidelberg Medical Center
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhasePhase 3
SponsorJanssen Research & Development, LLC
Started2022-10-25
Est. completion2031-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations63 sites
View on ClinicalTrials.gov →
NCT05552222