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Not yet recruitingNCT07811986BEYOND-MM 001Updated Sep 10, 2026

HP-001 Plus Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease

A Phase 2 interventional study of HP-001 and Dexamethasone in Multiple Myeloma (MM), sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Multiple Myeloma (MM)

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Keywords

  • extramedullary multiple myeloma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years at the time of signing informed consent; male or female.
  2. ECOG performance status of 0-2.
  3. 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.
  4. 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.
  5. 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.
  6. Willing and able to comply with study procedures and follow-up.

Exclusion criteria

Exclusion Criteria

  1. Smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary/secondary plasma cell leukemia.
  2. Central nervous system involvement or clinical evidence of meningeal involvement.
  3. 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.
  4. Major surgery within 4 weeks before the first dose or planned major surgery during the study.
  5. 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.
  6. Concurrent malignancy or other serious concomitant disease that may compromise participant safety or completion of the study.
  7. Pregnant or breastfeeding women.
  8. History of severe allergy or hypersensitivity to any component of the study treatment.
  9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    HP-001 Plus Dexamethasone

    Participants will receive HP-001 capsules at 0.6 mg orally once daily on Days 1-10 of each 28-day treatment cycle, in combination with dexamethasone 40 mg administered orally or intravenously on Days 1, 8, 15, and 22 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, the investigator determines that continued treatment is no longer appropriate, or completion of 24 treatment cycles, whichever occurs first.

    Drug: HP-001 · Drug: Dexamethasone

Interventions

  • DrugHP-001

    HP-001 capsules will be administered orally at a dose of 0.6 mg once daily on Days 1-10 of each 28-day treatment cycle.

  • DrugDexamethasone

    Dexamethasone will be administered at a dose of 40 mg orally or intravenously on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

05

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).

Secondary outcomes

  1. Extramedullary Disease Objective Response Rate (EMD-ORR)

    Time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).

  2. Very Good Partial Response or Better Rate (≥VGPR Rate)

    Time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).

  3. Complete Response or Stringent Complete Response Rate (CR/sCR Rate)

    Time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).

  4. Time to Response (TTR)

    Time frame: From the first dose to the date of the first documented overall response of PR or better, assessed through the end of Cycle 24 (each cycle is 28 days).

  5. Duration of Response (DoR)

    Time frame: From the date of the first documented overall response of PR or better to the date of disease progression or death from any cause, whichever occurs first, with follow-up through 12 months after the last dose.

  6. Progression-Free Survival (PFS)

    Time frame: From the date of the first dose to the date of disease progression or death from any cause, whichever occurs first, with follow-up through 12 months after the last dose.

  7. Overall Survival (OS)

    Time frame: From the date of the first dose to the date of death from any cause, with follow-up through 12 months after the last dose.

  8. Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to 2 years.

06

Study locations

1 site
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, 300000
    Tianjin, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07811986
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Gang An, PhD&MD
Contact
angang@ihcams.ac.cn
13502181109

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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