Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06158412

All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19

25

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To investigate the safety and efficacy of the ATRA combined with the KPD regimen in patients with refractory relapsed multiple myeloma.

CONDITIONS

Official Title

All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with multiple myeloma with 10% or more monoclonal plasma cells in bone marrow confirmed by history or biopsy
  • Measurable disease with specified levels of serum or urine M protein or abnormal free light chain ratio
  • Diagnosed with refractory or relapsed multiple myeloma based on defined disease progression criteria
  • ECOG performance status of 0, 1, or 2
  • Life expectancy of at least 3 months
  • Ability to read, understand, and sign informed consent form
Not Eligible

You will not qualify if you...

  • Currently participating or planning to participate in any other interventional clinical study
  • Investigator considers patient unsuitable for this study
  • Non-secretory myeloma
  • Received antimyeloma therapy or high-dose corticosteroids within 2 weeks before treatment
  • Received allogeneic stem cell transplant within 1 year or used immunosuppressive drugs within 1 month prior to enrollment
  • Inadequate bone marrow reserve (low platelet or neutrophil counts)
  • Clinically significant lung disease including COPD with FEV1 less than 50% or uncontrolled moderate/severe asthma
  • Significant cardiac disease including recent myocardial infarction, unstable angina, heart failure class III-IV, severe arrhythmia, or QT interval over 470 ms
  • Severe liver dysfunction unless related to myeloma
  • Creatinine clearance less than 20 mL/min
  • Known allergy to study drug components or severe hypersensitivity
  • Serious uncontrolled medical conditions that may interfere with study participation
  • HIV positive or active hepatitis B or C
  • History of active cancer within past 5 years except certain skin or cervical cancers
  • Unable to comply with study protocol due to substance abuse or psychological disorders
  • Pregnant or breastfeeding females
  • Peripheral neuritis grade 3 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bing Xu

Xiamen, Fujian, China, 361000

Actively Recruiting

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Research Team

Z

Zhijuan Lin, PhD

CONTACT

B

Bing Xu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma | DecenTrialz