NCT06158412

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Trans-Retinoic acid (ATRA) combined with the KPD regimen in patients with refractory relapsed multiple myeloma.

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
DRUG	All-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.

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-12-06
• Last updated: 2025-02-19

Locations

1 site across 1 country: China