Alternative dosing scheme of pomalidomide 4 mg every other day versus pomalidomide 2 mg and 4 mg every day: reduction in costs, same efficacy? A PKPD bioequivalence pilot study - the POMAlternative study
- Conditions
- Multiple myeloma10035227
- Registration Number
- NL-OMON53932
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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
• 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
• Thrombocytes <100 *10^9/L
• Neutrophiles <1.0 *10^9/L
• Pregnant patients
• Female patients who are able to get pregnant and who do not agree to adequate
birth control or complete abstinence (see appendix G, protocol)
• Male patients who do not agree to adequate birth control or complete
abstinence (see appendix G, protocol)
• Hypersensitivity to pomalidomide or constituents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The AUC/MIC ratio and the level of the Ctrough during usage of pomalidomide 4<br /><br>mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of<br /><br>28 days.</p><br>
- Secondary Outcome Measures
Name Time Method