Alternative dosing scheme of pomalidomide 4 mg every other day versus pomalidomide 2 mg and 4 mg every day: reduction in costs, same efficacy?
- Conditions
- Multiple myelomaTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2021-006646-12-NL
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
• Patients with relapsed/refractory multiple myeloma, who are eligible for a treatment regimen which contains pomalidomide. Either monotherapy or in combination with bortezomib, daratumumab, cyclophosphamide, or elotuzumab.
• Patients who received a minimum of two cycles of pomalidomide 4mg every day on day 1-21/28.
• Age > 18 years
• WHO performance status 0-3
• Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
• Usage of CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin, ketoconazole, carbamazepine, fluvoxamine, and grapefruit juice)
• Renal insufficiency requiring dialysis
• Significant hepatic dysfunction (total bilirubin =>30 micromol/l or transaminases => 3 times normal level)
• Current smoker
• Hemoglobin <6.5 mmol/L
• Thrombocytes <100 *10^9/L
• Neutrophiles <1.5 *10^9/L
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.