RecruitingPhase 2NCT06158412

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

A Single-center, Prospective, Single-arm Clinical Study of All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma (MM)

Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

25 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma in Relapse Multiple Myeloma, Refractory

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing all-trans retinoic acid (ATRA) — a form of vitamin A used in some blood cancers — combined with a regimen called KPD (carfilzomib, pomalidomide, and dexamethasone) in patients with multiple myeloma (a blood cancer) that has relapsed or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with multiple myeloma that has come back or stopped responding to treatment - Your myeloma has measurable markers in the blood or urine - You have received prior treatment but still have active, measurable disease - Your general health and organ function meet the required criteria **You may NOT be eligible if...** - You have never been treated for multiple myeloma (this is for relapsed/refractory patients) - Your organ function or health status does not meet the required thresholds - You have conditions that make the study drugs unsafe to use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAll-trans Retinoic Acid in combination with the KPD Regimen

Regimen: 1 course of treatment for 28 days until disease progression or intolerable toxicity occurs 1. ATRA mg/m2/day in 2 oral doses for 3 days. The first dose of ATRA will be given in the morning, two days prior to carfilzomib administration. The last ATRA dose will be given in the evening on the day of carfilzomib administration. 2. Proteasome inhibitor: Carfilzomib 27mg/m2 2 consecutive days per week x 3 weeks (20mg/m2 on day 1 and day 2 of cycle 1); 3. Pomalidomide 4mg orally daily, d1-21; 4. Dexamethasone given orally only on days 1, 8, 15, and 22 of each cycle; ≤75 years: 40 mg/day; \>75 years: 20 mg/day.