Evaluating TQB2029 injection for treating multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to assess the maximum tolerated dose and safety of TQB2029 injection in adult patients with multiple myeloma. It consists of two phases: Phase Ia focuses on dose escalation to determine safety and tolerability, while Phase Ib evaluates the effectiveness of the treatment. Participants will be monitored for adverse events and pharmacokinetic parameters to understand the drug's impact on the disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China hospital, Sichuan university
  Chengdu, Sichuan, China Recruiting
• Zhongshan Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Ting Niu, Doctor
• Email: tingniu@sina.com
• Phone: 028-85423046

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.