Actively Recruiting
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Led by North Estonia Medical Centre · Updated on 2024-07-17
50
Participants Needed
7
Research Sites
223 weeks
Total Duration
On this page
Sponsors
N
North Estonia Medical Centre
Lead Sponsor
J
Janssen Pharmaceutica
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.
CONDITIONS
Official Title
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented multiple myeloma meeting IMWG criteria
- Newly diagnosed and eligible for high-dose therapy and autologous stem cell transplant
- ECOG performance status of 2 or less
- HIV-positive individuals allowed if viral load is undetectable, CD4+ count above 300 cells/mm3, no recent AIDS-defining infections, and on stable HAART
- Signed informed consent form
- Willing and able to follow study lifestyle restrictions
- Negative pregnancy test for females of childbearing potential
- Females must be not of childbearing potential or use effective contraception
- Females must agree not to donate eggs during the study and for 6 months after last treatment
- Males must use condoms during sexual activity and agree not to donate sperm during the study and for 100 days after last treatment
- Meet specified lab values: hemoglobin ≥8 g/dL, platelets ≥75×10⁹/L, ANC ≥1.0×10⁹/L, AST and ALT ≤2.5× upper limit, eGFR ≥30 mL/min, total bilirubin <1.5× upper limit
You will not qualify if you...
- Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis
- Active central nervous system involvement or meningeal signs of multiple myeloma
- Peripheral neuropathy or neuropathic pain grade 2 or higher
- Ongoing myelodysplastic syndrome or other B cell malignancies besides multiple myeloma
- History of high-risk or active malignancies other than multiple myeloma with some exceptions for certain treated cancers
- Stroke within 6 months prior to enrollment
- Severe cardiac conditions including advanced heart failure, recent heart attack or bypass surgery, unstable angina, uncontrolled arrhythmia, severe cardiomyopathy
- Medical or psychiatric conditions likely to interfere with study or participant safety such as uncontrolled diabetes, active systemic infections, certain autoimmune diseases, gastrointestinal disorders affecting drug absorption, or severe psychiatric disorders
- Any condition impairing ability to tolerate treatment or understand consent
- Allergies or intolerance to study drugs or their components
- Hepatitis B or active hepatitis C infection
- Prior systemic therapy or stem cell transplant for plasma cell diseases except short corticosteroid use
- Major surgery within 2 weeks before or planned during study treatment period
- Contraindications to Dara-VRd per prescribing information
- Recent use of investigational vaccines, live vaccines, monoclonal antibodies, or strong CYP3A4 inducers within specified timeframes
- Pregnancy, breastfeeding, or plans to become pregnant or father a child during study or within specified post-treatment periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark, 2100
Not Yet Recruiting
2
Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
3
Vejle hospital
Vejle, Denmark, 7100
Not Yet Recruiting
4
North Estonia Medical Centre
Tallinn, Estonia, 13419
Actively Recruiting
5
Oslo University Hospital, Oslo Myeloma Centre
Oslo, Norway, 0450
Not Yet Recruiting
6
Stavanger University Hospital
Stavanger, Norway, 4068
Not Yet Recruiting
7
St. Olavs Hospital
Trondheim, Norway, 7030
Not Yet Recruiting
Research Team
D
Diana Loigom, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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