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A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Bu çalışma, multipl miyelom (multiple myeloma) adı verilen bir kemik iliği kanseri olan hastalarda enjeksiyonluk TQB2029 ilacını değerlendiriyor. Çalışmaya, 18-75 yaş arasında, tanısı belgelenmiş ve genel durumu ile organ işlevleri uygun olan kişiler katılabiliyor. Faz 1 aşamasında yürütülmekte olup halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Subjects who voluntarily join the study, sign the informed consent form, and have good compliance. * Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period. * Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria * There are measurable lesions present * The function of main organs is normal. * Subjects need to adopt effective methods of contraception. Exclusion Criteria: * Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration. * Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication * Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. * Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication * Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment * Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication * Subjects who have experienced arterial/venous thrombotic event occurred within 6 months prior to the first administration * Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders; * Subjects with any severe and/or uncontrolled disease * According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.