Relapsed or Refractory Multiple Myeloma
Conditions
Brief summary
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.
Interventions
DRUGQLS32015
QLS32015 will be administered subcutaneously
DRUGPomalidomide
Pomalidomide will be self-administered as a single dose orally
DRUGDexamethasone
Dexamethasone will be administered orally or intravenously
DRUGQL2109 or Daratumumab
QL2109 or Daratumumab will be administered subcutaneously.
DRUGBortezomib
Bortezomib will be administered subcutaneously
DRUGLenalidomide
Lenalidomide will be self-administered as a single dose orally
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria; * Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy; * Measurable disease at screening, defined by at least one of the following: * Serum M-protein ≥1.0 g/dL (10 g/L); * Urine M-protein ≥200 mg/24 hours; * Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio.
Exclusion criteria
* History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy); * Prior anti-myeloma therapies within the specified timeframes before enrollment: * Previous treatment with GPRC5D-targeted therapy; * Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell \[CAR-T\], natural killer \[NK\] cell therapy) within 3 months; * Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer); * Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer); * Cytotoxic therapy or monoclonal antibodies within 21 days; * Proteasome inhibitor therapy within 14 days; * Immunomodulatory drug therapy within 7 days; * Radiotherapy within 14 days (except low-dose palliative radiation \[10-30 Gy\]); * Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide); * Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid); * Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide); * Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR (Partial Response [PR] or Better) | Up to 2 years | Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria |
| Overall Minimal Residual Disease (MRD) | Up to 2 years | MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 2 years | PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first |
Countries
China
Contacts
CONTACTGang An, Professor
Outcome results
None listed