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

Last updated: April 16, 2025
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Completed

Phase

4

Condition

Multiple Myeloma

Platelet Disorders

Bone Neoplasm

Treatment

Pomalidomide 2 mg every day in cycle 2

Pomalidomide 4 mg every day in cycle 1

Pomalidomide 4 mg every other day in cycle 3

Clinical Study ID

NCT05555329
POMAlternative
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with relapsed/refractory multiple myeloma, who are eligible for a treatmentregimen which contains pomalidomide. Either monotherapy or in combination withbortezomib, 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

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 > 330 μmol/l or transaminases > 3times normal level)

  • Current smoker

  • Hemoglobin <6.5 mmol/L

  • 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 birthcontrol or complete abstinence

  • Male patients who do not agree to adequate birth control or complete abstinence

  • Hypersensitivity to pomalidomide or constituents

Study Design

Total Participants: 12
Treatment Group(s): 5
Primary Treatment: Pomalidomide 2 mg every day in cycle 2
Phase: 4
Study Start date:
December 01, 2022
Estimated Completion Date:
February 14, 2024

Study Description

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.

Connect with a study center

  • VUMedicalCenter

    Amsterdam,
    Netherlands

    Site Not Available

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