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New treatment option for Multiple Myeloma
Official title 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
ClinicalTrials.gov ID: NCT05552222
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as JNJ-64007957.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Tucson, Arizona, United States
- Clovis, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Farmington, Connecticut, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Weston, Florida, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Waukee, Iowa, United States
- Louisville, Kentucky, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
+ 212 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Tucson, Arizona, United States; Clovis, California, United States; Duarte, California, United States; Irvine, California, United States; Los Alamitos, California, United States and 226 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.