F182112 given with other drugs for relapsed or refractory 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 is a single-arm, multi-cohort, open-label Phase II study testing F182112 combined with different administration regimens in about 90 patients with relapsed or refractory multiple myeloma across roughly 20 centers. Participants must have prior exposure to lenalidomide (at least two continuous cycles) and a proteasome inhibitor, and those previously treated with or intolerant to pomalidomide are excluded. The primary endpoint is objective response rate (ORR), with secondary endpoints including complete response rate, progression-free survival, overall survival, duration and time to response, MRD-negativity, and safety outcomes. Two combination regimens listed are F182112+P and F182112+CD38, and the trial will monitor adverse events and laboratory abnormalities throughout treatment and follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.
* The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.
* Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.
* Have an ECOG performance status score of 0 - 2.
* Meet at least one of the following measurable disease indicators:

  1. Serum M - protein ≥ 5 g/L.
  2. Urine M - protein ≥ 200 mg/24 h.
  3. Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (\< 0.26 or \> 1.65).

Exclusion Criteria:

* Patients with primary light - chain amyloidosis or plasma cell leukemia .
* Patients with symptoms of central nervous system involvement of multiple myeloma.
* Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.
* Patients with active mucosal or visceral bleeding.
* Patients who have previously received BCMA - targeted therapy.

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Lu gui Qiu Doctor
• Email: Qiulg@ihcams.ac.cn
• Phone: （+86）13821266636

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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.