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

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 - POMAlternative

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53932

Enrollment

Registered

2022-08-10

Start date

2022-11-28

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Multiple myeloma

Interventions

A cross-over design with 12 patients in three cycles of 28 days: Group A (6 patients): C1: 4 mg QD day 1-21

C2: 4 mg EOD day 1-21

C3: 2 mg QD day 1-28 Group B (6 patients): C1: 4 mg QD day 1-21

C2: 2 mg QD day 1-28

C3: 4 mg EOD day 1-21

Eligibility

Age

18 Years to 99 Years

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

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 • Thrombocytes

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secondary endpoints: - 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.	—

Measure

Time frame

Secondary endpoints: - 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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)