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

NCT05555329 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-22

No results posted yet for this 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.

Conditions

Interventions

DRUG

Pomalidomide 4 mg every day in cycle 1

Pomalidomide 4 mg every day, on days 1-21 in a cycle of 28 days

DRUG

Pomalidomide 4 mg every other day in cycle 2

Pomalidomide 4 mg every other day, on days 1-21 in a cycle of 28 days

DRUG

Pomalidomide 2 mg every day in cycle 2

Pomalidomide 2 mg every day, on days 1-28 in a cycle of 28 days

DRUG

Pomalidomide 2 mg every day in cycle 3

Pomalidomide 2 mg every day, on days 1-28 in a cycle of 28 days

DRUG

Pomalidomide 4 mg every other day in cycle 3

Pomalidomide 4 mg every other day, on days 1-21 in a cycle of 28 days

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Sonja Zweegman, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-02-14
Completion
2024-02-14

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555329 on ClinicalTrials.gov