NCT05555329CompletedPhase 4

Alternative Dosing Scheme of Pomalidomide 4 mg Every Other Day Versus Pomalidomide 2 mg and 4 mg Every Day; 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

Source: ClinicalTrials.gov · Last updated 22 Apr 2025

Brief summary (registry, in English)

Pomalidomide either as single therapy or in combination with cyclophosphamide, elotuzumab, bortezomib, or daratumumab are effective treatment regimens in relapsed refractory multiple myeloma (RRMM). Standard dosing is 4 mg/day during 21 days of a 28-day cycle (21/28). However, a clear dose-response association for pomalidomide in patients with multiple myeloma (MM) is lacking. There is data supporting that a dose of 2 mg/day continuously (28/28) induces fewer side effects while efficacy is preserved, compared to 4 mg/day continuously. The response in patients who received pomalidomide 2 mg per day compared to 4 mg per day was higher, with a longer duration of response. In addition, a randomized phase II study showed no difference in efficacy between 4 mg (21/28) and 4 mg continuously. These clinical studies support that a dosage of pomalidomide of 2 mg (28/28) is at least comparable with a dosage of 4 mg (21/28). It is not known if 4 mg every other day (EOD) is comparable to a dosage of pomalidomide 2 mg (28/28) or 4 mg every day (QD, 21/28). For cost reasons, this is interesting as the costs of pomalidomide 4 mg and 2 mg are comparable. Therefore, from a patient and societal perspective, the investigators want to explore if an alternative scheme would be possible by performing a PKPD bio-equivalence pilot study.

Status (registry): Completed
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 12 (actual)
First submitted: 20 Sept 2022
Start date: 1 Dec 2022
Primary completion date: 14 Feb 2024
Lead sponsor: Amsterdam UMC, location VUmc
Diseases: Multiple myeloma
NCT number: NCT05555329

What you commit to

Study type: Interventional · Phase 4
Participants enrolled: 12
From 1 Dec 2022 to the primary completion date, 14 Feb 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Usage of CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin, ketoconazole, carbamazepine, fluvoxamine, and grapefruit juice)

Other illness

Renal insufficiency requiring dialysis
Hypersensitivity to pomalidomide or constituents

Lab values

Significant hepatic dysfunction (total bilirubin \> 330 μmol/l or transaminases \> 3 times normal level)
Hemoglobin \<6.5 mmol/L

Other

Current smoker
Thrombocytes \<100 \*10\^9/L
Neutrophiles \<1.5 \*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
Male patients who do not agree to adequate birth control or complete abstinence

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
VUMedicalCenter Coordinator of this site? Confirm its status	Amsterdam	Netherlands	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.