Oral drug combo targets myeloma that escaped the bone marrow
NCT ID NCT07811986
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing an experimental oral drug called HP-001 alongside dexamethasone in adults whose multiple myeloma has returned after treatment and has formed tumors outside the bone marrow. Participants take HP-001 capsules once daily for 10 days of each 28-day cycle, plus dexamethasone on four days per cycle. The trial aims to see how many people respond to the combination and how long responses last, while tracking side effects. About 20 people will join at a single center in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HP-001, an experimental oral drug, given with dexamethasone
- What this could lead to
- If it works, this combination could offer a new oral option for myeloma that has come back and spread beyond the bone marrow, a hard-to-treat situation.
- What could go wrong
- This is a small, early-stage trial with 20 participants and no comparison group, so any benefit seen may not hold up in larger studies. HP-001 is experimental, and combining it with dexamethasone may cause side effects that limit its use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, 300000
Tianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple-Drug combo aims to deepen myeloma response before transplant
- Cell therapy targets a marker on myeloma cells
- Can a Four-Drug combo tame Ultra-High-Risk myeloma?
- MRI scans may reveal hidden clues to myeloma relapse risk
- Can a dual immunotherapy erase hidden myeloma cells?
- Does CAR-T therapy affect the brain? a study investigates