Alternative dosing scheme of pomalidomide 4 mg every other day versus pomalidomide 2 mg and 4 mg every day: reduction in costs, same efficacy?

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. - Alternative dosing scheme of pomalidomide 4 mg every other day; reduction in costs, same efficacy?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006646-12-NL

Enrollment

Registered

2022-08-13

Start date

2024-04-25

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

Trade Name: Pomalidomide (Imnovid) Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess in which percentage of patients the AUC is above the MIC and the level of the Ctrough above the EC50 during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of 28 days.;Secondary Objective: - To assess other pharmacokinetic (PK) (i.e., maximum serum concentration (Cmax) and time above EC50) parameters during usage of pomalidomide 4 mg every day, pomalidomide 4 mg every other day, and pomalidomide 2 mg every day. - To assess toxicity and side effects during all to be studied dosages. - To assess response during all to be studied dosages. Explorative: - To assess the level of T-cell activation, defined as the expression of membrane activation markers and cytokine markers during usage of all to be studied dosages. - To assess Ikaros/Aiolos degradation levels as a biological measurement of pomalidomide activation during usage of all to be studied dosages. - To assess the concentration of pomalidomide in mononuclear cells (PBMCs) during usage of all to be studied dosages. ;Primary end point(s): The AUC/MIC ratio and the level of the Ctrough during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of 28 days.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the last of 12 patients completed the whole study.	—

Measure

Time frame

Main Objective: To assess in which percentage of patients the AUC is above the MIC and the level of the Ctrough above the EC50 during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of 28 days.;Secondary Objective: - To assess other pharmacokinetic (PK) (i.e., maximum serum concentration (Cmax) and time above EC50) parameters during usage of pomalidomide 4 mg every day, pomalidomide 4 mg every other day, and pomalidomide 2 mg every day. - To assess toxicity and side effects during all to be studied dosages. - To assess response during all to be studied dosages. Explorative: - To assess the level of T-cell activation, defined as the expression of membrane activation markers and cytokine markers during usage of all to be studied dosages. - To assess Ikaros/Aiolos degradation levels as a biological measurement of pomalidomide activation during usage of all to be studied dosages. - To assess the concentration of pomalidomide in mononuclear cells (PBMCs) during usage of all to be studied dosages. ;Primary end point(s): The AUC/MIC ratio and the level of the Ctrough during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1-21, and 2 mg QD on day 1-28 in cycles of 28 days.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the last of 12 patients completed the whole study.

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Secondary

Measure	Time frame
Secondary end point(s): - Other PK parameters (Cmax and time above EC50) during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1- 21, and 2 mg QD on day 1-28 in cycles of 28 days. - Toxicity and side effects during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days. - Overall response rate (ORR) Explorative endpoints: - T-cell activation, defined as the expression of membrane activation markers and cytokine markers during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days. - Ikaros/Aiolos degradation as a biological measurement of pomalidomide activation during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days. - Concentration of pomalidomide in PBMCs during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days.;Timepoint(s) of evaluation of this end point: Toxicity, side effects and response will be evaluated during and after completion of the study. All other endpoints will be evaluated after all 12 patients completed the study.	—

Measure

Time frame

Secondary end point(s): - Other PK parameters (Cmax and time above EC50) during usage of pomalidomide 4 mg QD on day 1-21, 4 mg EOD on day 1- 21, and 2 mg QD on day 1-28 in cycles of 28 days. - Toxicity and side effects during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days. - Overall response rate (ORR) Explorative endpoints: - T-cell activation, defined as the expression of membrane activation markers and cytokine markers during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days. - Ikaros/Aiolos degradation as a biological measurement of pomalidomide activation during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days. - Concentration of pomalidomide in PBMCs during usage of pomalidomide 4 mg every day on day 1-21, pomalidomide 4 mg every other day on day 1-21, and pomalidomide 2 mg every day on day 1-28 in cycles of 28 days.;Timepoint(s) of evaluation of this end point: Toxicity, side effects and response will be evaluated during and after completion of the study. All other endpoints will be evaluated after all 12 patients completed the study.

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Countries

Netherlands

Contacts

Public ContactClinical Trial Office Hematology

Amsterdam UMC

hemtrial@vumc.nl+3120444 2345

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026