MajesTEC-7
Research type
Research Study
Full 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
IRAS ID
1005985
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2022-000909-28
ISRCTN Number
ISRCTN72661732
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma (MM) is a blood cancer that forms in a type of white blood cells (WBCs) called plasma cells. Drugs that deviate T-cells (type of WBCs) to attack cancer cells may be an effective way to destroy them.
Tec is a modified antibody (a protein made in the body against foreign matter) that binds to T-cells and MM cells, activates T-cells and leads to killing of MM cells.
This study is designed to see if Tec-DR prevents MM from getting worse for longer period of time compared to DRd in participants with newly diagnosed MM who are either not eligible or for whom autologous stem cell transplant (ASCT)* is not planned as initial therapy.
*Collection and storage of a person’s own healthy stem cells; given back to support intensive chemotherapy treatment.
Study will include male and female participants 18 years or older.
This study consists of Screening, Treatment, and Follow‐up Phases. Participants will receive either Tec-DR or DRd, as described below.
Tec-DR
• Tec – based on body weight
- 2 Step up doses followed by treatment dose 1 on Days 8, 15, and 22 of Cycle 1 and weekly (Days 1, 8, 15 and 22) in Cycle 2; treatment dose 2 every 2 weeks (Q2W) on Days 1 and 15 of Cycle 3 to 6 and every 4 weeks (Q4W) on Day 1 of Cycle 7 and onward as an injection under the skin.
• DR
- D weekly in Cycles 1 and 2, Q2W on Days 1 and 15 of Cycles 3 to 6, Q4W on Day 1 of Cycle 7 and onward as an injection under the skin.
- R by mouth on Days 1 to 21 from Cycle 2 onwards.
- In addition, Dexamethasone is given by mouth or as injection in vein weekly in Cycles 2 to 4 only.
DRd
• D similar to group 1.
• R by mouth on Days 1 to 21 from Cycle 1.
• d by mouth or as injection in vein, weekly from Cycle 1.
Each cycle will consist of 28 days.
Participants will undergo study assessments such as blood and urine tests, imaging, bone-marrow testing, physical and neurological examinations, and questionnaires. Serious side effects will be recorded until study ends.REC name
West of Scotland REC 1
REC reference
22/WS/0162
Date of REC Opinion
23 Jan 2023
REC opinion
Further Information Favourable Opinion