Health TrialsbyHealthPanel

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

ConditionMultiple Myeloma (MM)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • HP-001

    Drug

    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.

  • Dexamethasone

    Drug

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: HP-001 Plus DexamethasoneExperimental treatment 2 interventions

Trial outcomes

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: