Actively Recruiting
A Single-center, Prospective, Single-arm Study of All-trans Retinoic Acid with KPD Regimen for Refractory/Relapsed Multiple Myeloma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining All-trans Retinoic Acid (ATRA) with a KPD regimen in patients who have refractory or relapsed multiple myeloma. This open-label Phase 2 clinical trial aims to measure response rates, survival times, and side effects associated with this treatment combination. The treatment involves a 28-day course where patients receive ATRA orally twice daily for three days, starting two days before carfilzomib administration. The KPD regimen includes carfilzomib given twice weekly for three weeks, pomalidomide taken orally daily for 21 days, and dexamethasone administered orally on specific days each cycle with doses adjusted by age. Treatment continues until disease progression or unacceptable toxicity. Participants will undergo regular assessments for overall response rate, complete response, progression-free survival, and overall survival for up to 26 months. Evaluations include clinical exams, laboratory tests, and monitoring for adverse effects. The study ensures ongoing safety monitoring and follows participants throughout the treatment and observation periods to gather comprehensive data on treatment impact and tolerability.
CONDITIONS
Brief Title
All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of multiple myeloma with at least 10% monoclonal plasma cells in bone marrow
- Measurable disease defined by specific protein levels in blood or urine
- Diagnosis of refractory or relapsed multiple myeloma based on disease progression or response
- ECOG performance status of 0, 1, or 2
- Life expectancy of at least 3 months
- Ability to read, understand, and sign informed consent
You will not qualify if you...
- Currently participating or planning to participate in another interventional clinical study
- Investigator considers patient unsuitable for participation
- Non-secretory myeloma
- Received antimyeloma therapy within 2 weeks prior to treatment start
- Previous allogeneic stem cell transplant within 1 year without recent immunosuppressive medications
- Inadequate bone marrow reserve with low platelet or neutrophil counts
- Clinically significant lung disease or uncontrolled asthma
- Significant cardiac disease or abnormalities including recent heart attack or arrhythmia
- Severe liver dysfunction unless related to myeloma
- Kidney function with creatinine clearance below 20 mL/min
- Known allergy or severe hypersensitivity to study product components
- Serious uncontrolled medical conditions that may interfere with study or pose risk
- HIV positive or active hepatitis B or C infection
- History of active malignancy within past 5 years except certain skin or cervical cancers
- Inability 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 course of treatment for 28 days until disease progression or intolerable toxicity occurs
Participants receive All-trans Retinoic Acid combined with the KPD regimen in 28-day cycles until disease progression or intolerable toxicity occurs.
Multiple visits per cycle including oral doses of medication on specific days and carfilzomib administered 2 consecutive days per week for 3 weeks
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
Z
Zhijuan Lin, PhD
B
Bing Xu, PhD
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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