An open label, multicenter, Phase 2, pilot study, evaluating early treatment with bispecific T-cell redirectors (teclistamab and talquetamab) in the therapy of newly diagnosed high -risk multiple myeloma
- Conditions
- Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-514016-26-00
- Lead Sponsor
- Fundacion Pethema
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements, A female of childbearing potential must have a negative highly sensitive urine or serum (ß human chorionic gonadotropin [ß hCG]) pregnancy test at screening and 24h prior to the start of study treatment and must agree to further urine or serum pregnancy tests during the study, A woman must be: a. Not of childbearing potential, or b. Of childbearing potential and i. Practicing true abstinence; or ii. Have a sole partner who is vasectomized; or iii. Practicing 2 methods of contraception (at least 1 highly-effective), A female patient must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study treatment, A male patient must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 3 months after receiving the last dose of study treatment. Male participants must also be advised of the benefit for a female partner to use a highly effective method of contraception as condoms may break or leak., A male patients must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment., Patient must be willing and able to adhere to the lifestyle restrictions specified in the protocol (Section 4.3), All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 5.0 must be = Grade 1 at the time of enrolment except for alopecia., Patient has given voluntary written informed consent before performance of any study-related procedure nor part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care., Patient is = 18 years of age at the time of informed consent, Patient has documented diagnosis of multiple myeloma according to IMWG diagnostic criteria, with at least one of the following high-risk features: a)High-risk FISH: del(1p), del(17p), t(4;14), t(14;16) and 1q amplifications. b)R-ISS 3. c)Presence of extramedullary disease, defined as presence of paramedullary lesions or extramedullary plasmacytoma., Patient has measurable secretory disease defined as either serum monoclonal protein of = 0.5 g/dl or urine monoclonal (light chain) protein = 200 mg/24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be = 10mg/dL (100 mg/L), with an abnormal serum FLC ratio., Human inmunodeficiency virus-positive patients are elegible if the meet all of the following: a. No detectable viral load (ie, < 50 copies/mL) at screening b. CD4+ count > 300 cells/mm3 at screening c. No AIDS defining opportunistic infection within 6 months of screening d. Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening., Patients eligible for transplant with age =70 years old (young and transplant-eligible) or patients not eligible for transplant with ECOG-PS modified frailty score of 0-1., Patient has an ECOG performance status of 0, 1or 2., Patient must have adequate organ function, defined in: Hemoglobin = 8 g/dL, Platelets = 75 x 109/L in participa
Prior or current systemic therapy or SCT for any plasma cell dyscrasia, with the exception of 1 cycle of antimyeloma treatment or the emergency use of a short course of corticosteroids before treatment while waiting for results of genetic analysis, Patient has CNS or exhibits clinical signs of meningeal involvement of MM, Patient is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment, Patient plans to father a child while enrolled in this study or within 3 months after the last dose of study treatment, Patient is simultaneously enrolled in other interventional CT, Patient has received prior radiotherapy within 2 weeks of start of study therapy. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (= 2 weeks of radiotherapy ) to non CNS disease, Prior or concurrent exposure to any of the following: -Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks -Live, attenuated vaccine within 4 weeks, before enrollment.Non-life vaccines authorized for emergency use (eg. COVID-19) and allowed (APPENDIX 22). - Monoclonal antibody therapy within 21 days (not use for the treatment of MM), Received a strong CYP3A4 inducer within 5 half-lives prior to starting study treatment, A maximum cumulative dose of corticosteroids of = 140 mg of prednisone or equivalent within 14 day period before the first dose of Tec-Dara or Tal-Dara, Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients, or sensitivity to mammalian-derived products or lenalidomide, Presence of the following cardiac conditions: a) New York Heart Association stage III or IV congestive heart failure (APPENDIX 19) b) Myocardial infarction or coronary artery bypass graft = 6 months prior to starting study treatment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities., Plasmapheresis within 28 days of starting study treatment defined as C1D1 of D-VRD., Stroke, transient ischemic attack or seizure within 6 months prior to signing ICF, Any of the following: -Hepatitis B infection (ie, HBsAg or HBV-DNA +). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status -Active hepatitis C infection as measured by + HCV-RNA testing. Patients with a history of HCV antibody + must undergo HCV-RNA testing. If a patient with history of chronic hepatitis C infection (HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the patient is eligible for the study, Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, COPD with a FEV1 < 50% of predicted normal. Note that FEV1 testing is required for patients with known or suspected of having COPD or asthma and patients must be excluded if FEV1 < 50% of predicted normal, Moderate or severe persistent asthma within t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method