Clinical Trials | 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

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been newly diagnosed with multiple myeloma. The purpose of this study is to compare 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. The drugs being studied are called teclistamab and talquetamab. Neither teclistamab nor talquetamab (alone or in combination with other medications) is approved for treatment of newly diagnosed multiple myeloma in any country by any Regulatory Authority, such as the FDA, that protects public health by overseeing safety and effectiveness of medications. Therefore, these can only be used in a research study such as this one. Not everyone in the study will get teclistamab or talquetamab. There are three study treatment groups in the randomized (like the flip of a coin) part of this study. You and your study doctor will know which study treatment you are receiving. You will have an equal chance of being put into any of the 3 groups: • Experimental Arm – you will receive teclistamab, daratumumab and lenalidomide also known as Tec-DR. You will also receive dexamethasone as a study drug in addition to these therapies for 2 cycles (Cycles 2 and 3). • Experimental Arm – you will receive talquetamab, daratumumab and lenalidomide also known as Tal-DR. You will also receive dexamethasone as a study drug in addition to these therapies for 2 cycles (Cycles 2 and 3). • Comparator Arm – you will receive daratumumab, lenalidomide and dexamethasone also known as DRd Teclistamab, talquetamab and daratumumab will be given via an injection with a small needle under the skin. Dexamethasone may be given as a pill or via intravenous (IV) administration. Lenalidomide will be given as a capsule. The study treatment period is divided into cycles. Each cycle lasts 28 days. The study is expected to continue for approximately 9 years. The duration of your participation will depend on how you respond to the study treatment. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT05552222 [email protected] Compensation: You will receive a $100 stipend per completed study visit. Reimbursement: You may receive reimbursement for lodging and travel to help with your expenses for attending study visits.