Recruiting NCT05552222

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

Phase III Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Teclistamab, Daratumumab, Lenalidomide, Dexamethasone.
Who it may be relevant to: Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Brazil +20
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy

Overview

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).

Interventions

Drug Teclistamab
Teclistamab will be administered as SC injection.
Drug Daratumumab
Daratumumab will be administered as SC injection.
Drug Lenalidomide
Lenalidomide will be administered orally.
Drug Dexamethasone
Dexamethasone will be administered either orally or intravenously (IV).
Drug Talquetamab
Talquetamab will be administered as SC injection.

Primary outcome measures

Progression Free Survival (PFS) [Time frame: From randomization to the date of disease progression or death (Up to 09 years)]
12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR) [Time frame: At Month 12]

Secondary outcome measures (12)

Very Good Partial Response (VGPR) or Better [Time frame: From randomization up to 09 years]
Complete Response (CR) or Better [Time frame: From randomization up to 09 years]
Sustained Minimal Residual disease (MRD)-negative Complete Response (CR) [Time frame: From randomization up to 09 years]
MRD-negative CR [Time frame: From randomization up to 09 years]
Progression Free Survival on Next-line Therapy (PFS2) [Time frame: From randomization up to 09 years]
Overall Survival (OS) [Time frame: From randomization to the date of death (up to 09 years)]
Number of Participants with Adverse Events (AEs) by Severity [Time frame: From randomization up to 09 years]
Number of Participants with Abnormalities in Laboratory Parameters [Time frame: From randomization up to 09 years]
Number of Participants with Abnormalities in Vital Signs [Time frame: From randomization up to 09 years]
Number of Participants with Abnormalities in Physical Examination [Time frame: From randomization up to 09 years]
Number of Participants with Abnormalities in Electrocardiogram (ECG) [Time frame: From randomization up to 09 years]
Serum Concentrations of Teclistamab and Talquetamab [Time frame: From randomization up to 09 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment