Combining teclistamab and talquetamab with daratumumab and lenalidomide for newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of two treatment combinations for patients with newly diagnosed multiple myeloma. Participants will receive either teclistamab combined with daratumumab and lenalidomide or talquetamab combined with daratumumab and lenalidomide, and these will be compared against a standard treatment of daratumumab, lenalidomide, and dexamethasone. The goal is to determine which combination provides better outcomes for patients who are not candidates for high-dose chemotherapy with autologous stem cell transplant.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• UCSF Fresno
  Clovis, California, United States Recruiting
• City of Hope Duarte
  Duarte, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Cancer and Blood Specialty Clinic
  Los Alamitos, California, United States Recruiting

+220 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.