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Clinical Study of Reduced-dose Pomalidomide and Cyclophosphamide Combined With Dexamethasone in the Treatment of Patients With Debilitating RRMM

NCT06255847 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-02-13

No results posted yet for this study

Summary

This is an open-label clinical study to evaluate the efficacy and safety of a multicenter, open-label clinical study of a base-reduced-dose pomalidomide, cyclophosphamide combined with dexamethasone (PCd) regimen for the treatment of patients with debilitating relapsed refractory multiple myeloma.

Subjects meeting the enrollment criteria were screened for entry into the study and treated with the appropriate regimen; all patients enrolled in the study did not receive medications other than those specified in the regimen for the treatment of myeloma during the study period, except for supportive care. The primary endpoint of the study is ORR; secondary study endpoints include efficacy above VGPR, progression-free survival (PFS), overall survival (OS), TTNT, safety, and life scale assessment.

Conditions

  • Multiple Myeloma in Relapse

Interventions

DRUG

Pomalidomide, cyclophosphamide combined with dexametha

The starting dose of pomalidomide was 2 mg in all cases，the starting dose of cyclophosphamide was 50 mg/day.If the adverse event is attributable to a specific study drug, the dose is reduced accordingly for that drug; if the adverse event is associated with multiple drugs, the dose is reduced appropriately for one of the predominantly associated drugs at the discretion of the investigator; and if multiple adverse events occur concurrently, the dose should be adjusted according to the guidelines for the most severe toxicity.

Sponsors & Collaborators

  • Shanxi Bethune Hospital

    lead OTHER

Principal Investigators

  • Xiaomin Zhang · Shanxi Bethune Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2025-06-15
Completion
2025-06-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06255847 on ClinicalTrials.gov