Actively Recruiting
A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-05-22
228
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of QLS32015 compared to two other treatments, Pomalidomide with Dexamethasone (Pd) and Selinexor with Dexamethasone (Sd), for people who have relapsed or refractory multiple myeloma. This phase 3 study focuses on patients who have already received several prior treatments, aiming to find better options for managing this condition. Participants will be randomly assigned to receive either QLS32015 alone, given by injection under the skin, or one of the other treatments chosen by the main investigator, either Pd or Sd, both taken by mouth. This study will monitor these treatments over time to compare their impacts on the disease. During the study, participants will be followed for up to four years to assess how long their disease stays under control without worsening, as well as their response to treatment. Researchers will also evaluate side effects, symptoms, physical functioning, and overall quality of life using questionnaires. Safety will be closely monitored throughout the study period.
CONDITIONS
Brief Title
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, regardless of gender
- Willing and able to comply with study schedule and protocols
- Documented initial diagnosis of multiple myeloma based on International Myeloma Working Group criteria
- Measurable disease with serum M-protein 0.5 g/dL, or urine M-protein 200 mg/24 hours, or involved serum free light chain level 10 mg/dL with abnormal ratio
- Received at least 3 prior therapy lines including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody
You will not qualify if you...
- Known allergy to any ingredients of study drugs
- Active plasma cell leukemia or systemic light chain amyloidosis
- Active severe mental or medical illness affecting treatment or consent
- Disease refractory to pomalidomide and selinexor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants receive one of the study drug regimens: QLS32015 monotherapy, or Pomalidomide and Dexamethasone (Pd), or Selinexor and Dexamethasone (Sd).
Regular visits as per treatment protocol
Trial Site Locations
Total: 1 location
1
National Clinical Research Center for Blood Diseases
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
G
Gang An, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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