Tests HP-001 with dexamethasone in relapsed myeloma with extramedullary disease
Tests HP-001 capsules with dexamethasone in adults with relapsed myeloma outside bone marrow.
Plain-language title generated from the registry record
Registry title: HP-001 Plus Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, 300000Tianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07811986
- Record updated
- 10 September 2026
- Original description
This is a prospective, single-arm, exploratory Phase II clinical study evaluating the efficacy and safety of HP-001 capsules in combination with dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) with extramedullary disease (EMD).Read full original descriptionShow less
A Prospective, Single-Arm, Exploratory Phase II Clinical Trial of HP-001 in Combination With Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
This is a prospective, single-arm, exploratory Phase II clinical study evaluating the efficacy and safety of HP-001 capsules in combination with dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) with extramedullary disease (EMD).
Inclusion: Age ≥18 years at the time of signing informed consent; male or female; ECOG performance status of 0-2; Diagnosis of multiple myeloma according to IMWG criteria, with relapsed/refractory disease after at least 1 prior systemic treatment regimen; disease progression or failure to achieve a response after the most recent line of therapy; and extramedullary disease confirmed by imaging, defined as at least 1 soft-tissue extramedullary lesion ≥2 cm, at least 1 paramedullary lesion ≥5 cm, or >2 lesions; With or without measurable hematologic disease at screening. Measurable disease, if present, is defined as serum M-protein ≥1.0 g/dL, urine M-protein ≥200 mg/24 hours, or serum free light chain ≥10 mg/dL with an abnormal free light chain ratio; Adequate organ function, including ANC ≥1.0 × 10⁹/L, hemoglobin ≥60 g/L, platelet count ≥50 × 10⁹/L, creatinine clearance ≥30 mL/min, total bilirubin ≤2 × ULN (≤3 × ULN for Gilbert syndrome), AST and ALT ≤2.5 × ULN, and INR or aPTT ≤1.5 × ULN; Willing and able to comply with study procedures and follow-up.
Exclusion: Severe or uncontrolled cardiovascular disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before enrollment, severe uncontrolled arrhythmia, or other cardiovascular/cerebrovascular conditions considered unsuitable by the investigator; Major surgery within 4 weeks before the first dose or planned major surgery during the study; Concurrent malignancy or other serious concomitant disease that may compromise participant safety or completion of the study; Smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary/secondary plasma cell leukemia; Active infection, including HIV infection, active hepatitis B (HBV-DNA positive), active hepatitis C (HCV-RNA positive), active or latent syphilis, active tuberculosis, or other active infections considered unsuitable by the investigator; History of severe allergy or hypersensitivity to any component of the study treatment; Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment; Central nervous system involvement or clinical evidence of meningeal involvement; Pregnant or breastfeeding women.