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New treatment option for Multiple Myeloma (MM)
Official title Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.
ClinicalTrials.gov ID: NCT07107529
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 (mm).
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
- This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab. The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).
- Phase 2: a mid-size study of how well it works
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
- Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the...
- Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria
- Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL [≥100 mg/L] and abnormal serum...
- Frail according to the Simplified IMWG frailty index
- Have clinical laboratory values meeting defined range
You likely can't join if
- Non-secretory MM or measurable disease by urine or plasmacytoma only
- Central nervous system involvement of myeloma
- Significant pulmonary dysfunction
- Stroke, transient ischemic attack, or seizure within 6 months of eligibility
- Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy
- HIV and Hepatitis infections
See the full eligibility criteria
- Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to...
- Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria
- Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL [≥100 mg/L] and abnormal serum immunoglobulin kappa/lambda FLC ratio
- Frail according to the Simplified IMWG frailty index
- Have clinical laboratory values meeting defined range
- Patients of childbearing potential must agree to use adequate/highly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug
- Non-secretory MM or measurable disease by urine or plasmacytoma only
- Central nervous system involvement of myeloma
- Significant pulmonary dysfunction
- Stroke, transient ischemic attack, or seizure within 6 months of eligibility
- Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy
- HIV and Hepatitis infections
- Exclude for any of the following:
- Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.
- Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.
- Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)
- Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility
- Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to \>40 mg dexamethasone within the 14 days prior to C1D1
- Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed
- Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing
- Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery
- Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device \<4 week or 5 PK half-lives, before eligibility or is currently enrolled in an treatment...
- Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that...
- Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the...
The study team makes the final eligibility decision.
Where it's taking place
- Ascoli Piceno, Italy
- Bari, Italy
- Bergamo, Italy
- Bologna, Italy
- Bolzano, Italy
- Como, Italy
- Milan, Italy
- Novara, Italy
- Pescara, Italy
- Roma, Italy
- Torino, Italy
- Varese, Italy
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Enschede, Netherlands
- Groningen, Netherlands
- Nieuwegein, Netherlands
- Schiedam, Netherlands
- Sittard, Netherlands
- The Hague, Netherlands
+ 7 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 Ascoli Piceno, Italy; Bari, Italy; Bergamo, Italy; Bologna, Italy; Bolzano, Italy; Como, Italy and 21 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.