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New treatment option for Relapsed or Refractory Multiple Myeloma
Official title A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07312188
What this study is testing
What is F182112+P?
F182112+P is an investigational medicine, being studied as a potential treatment for relapsed or refractory multiple myeloma.
Also referred to as F182112, Pomalidomide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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.
See the full eligibility 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:
- Serum M - protein ≥ 5 g/L.
- Urine M - protein ≥ 200 mg/24 h.
- Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (\ 1.65).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.