Multiple Myeloma (MM)Phase 2BEYOND-MM 001NCT07811986
HP-001 Plus Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
A Phase 2 study testing HP-001 and Dexamethasone in people with Multiple Myeloma (MM), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- HP-001 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary/secondary plasma cell leukemia.
- Central nervous system involvement or clinical evidence of meningeal involvement.
- 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.
- 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.
- Concurrent malignancy or other serious concomitant disease that may compromise participant safety or completion of the study.
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- Pregnant or breastfeeding women.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, 300000
Tianjin
Gang An, PhD&MD, 008613502181109, angang@ihcams.ac.cn
About this study
Official title: 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).
- Conditions
- Multiple Myeloma (MM)
- Being tested
- HP-001, Dexamethasone
- Keywords
- extramedullary multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP-001Drug
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.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HP-001 Plus Dexamethasone | Experimental | 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. Receives: Drug: HP-001; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: From the first dose to the end of Cycle 24 (each cycle is 28 days).
Secondary outcomes (8)
Extramedullary Disease Objective Response Rate (EMD-ORR)
Measured: From the first dose to the end of Cycle 24 (each cycle is 28 days).
Very Good Partial Response or Better Rate (≥VGPR Rate)
Measured: From the first dose to the end of Cycle 24 (each cycle is 28 days).
Complete Response or Stringent Complete Response Rate (CR/sCR Rate)
Measured: From the first dose to the end of Cycle 24 (each cycle is 28 days).
Time to Response (TTR)
Measured: 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).
Duration of Response (DoR)
Measured: 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.
Progression-Free Survival (PFS)
Measured: 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.
Overall Survival (OS)
Measured: 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.
Incidence and Severity of Adverse Events (AEs)
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811986
- Sponsor's protocol ID
- IIT2026091
- Acronym
- BEYOND-MM 001
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Exploratory Phase II Clinical Trial of HP-001 in Combination With Dexamethasone for Relapsed/Refractory Multiple Myeloma With Extramedullary Disease
- ClinicalTrials.gov ID
- NCT07811986
- Acronym / sponsor ID
- BEYOND-MM 001 / IIT2026091
- Conditions
- Multiple Myeloma (MM)
- Keywords
- extramedullary multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP-001 Plus Dexamethasone | Experimental | Drug: HP-001, Drug: DexamethasoneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary/secondary plasma cell leukemia.
- Central nervous system involvement or clinical evidence of meningeal involvement.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP-001HP-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. | Drug | HP-001 Plus Dexamethasone |
| DexamethasoneDexamethasone 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. | Drug | HP-001 Plus Dexamethasone |
Primary outcome
Overall Response Rate (ORR)
Time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).
8 secondary outcomes
Extramedullary Disease Objective Response Rate (EMD-ORR)
Time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).
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).
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).
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).
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.
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.
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.
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP-001 and Dexamethasone in people with Multiple Myeloma (MM), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang An, PhD&MD (13502181109, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From the first dose to the end of Cycle 24 (each cycle is 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.