F182112 given with other drugs for relapsed or refractory multiple myeloma

A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma

This trial will test whether F182112, given with different drug regimens, helps people whose multiple myeloma has returned or stopped responding to prior treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong New Time Pharmaceutical Co., LTD (Industry-sponsored)
• Locations: 1 site (Tianjin)
• Trial ID: NCT07312188 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with relapsed or refractory multiple myeloma per IMWG 2016 who have received lenalidomide continuously for at least two cycles and a proteasome inhibitor, have ECOG 0–2, and meet standard measurable disease criteria are the intended participants.

Not a fit: Patients previously treated with or intolerant to pomalidomide, those with primary light-chain amyloidosis or plasma cell leukemia, CNS involvement of myeloma, or a recent other malignancy are not eligible and likely will not benefit from participation.

Why it matters

Potential benefit: If successful, this could provide an additional treatment option that shrinks disease or prolongs remission for people whose multiple myeloma has relapsed or become resistant to standard drugs.

How similar studies have performed: Other combination approaches in relapsed/refractory myeloma—particularly those adding CD38-targeting antibodies—have shown clinical benefit, but F182112 itself appears to be a novel agent without large published Phase II/III results yet.

Eligibility criteria

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 this trial is running

Tianjin

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

Study contacts

• Study coordinator: Lu gui Qiu Doctor

Conditions Relapsed or Refractory Multiple Myeloma