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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

  • - 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 > 3 times 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 birth control or complete abstinence.
  • - Male patients who do not agree to adequate birth control or complete abstinence.
- Hypersensitivity to pomalidomide or constituents

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05555329
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Amsterdam UMC, location VUmc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sonja Zweegman, MD PhD
Principal Investigator Affiliation Amsterdam UMC, location VUmc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma, Refractory
Additional Details

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.

Arms & Interventions

Arms

Experimental: Group A; Pomalidomide 4 mg every other day in cycle 2

Group A (6 patients): Cycle 1: Pomalidomide 4 mg every day on day 1-21; Cycle 2: 4 mg every other day on day 1-21; Cycle 3: 2 mg every day on day 1-28. In Cycles of 28 days.

Experimental: Group B; Pomalidomide 4 mg every other day in cycle 3

Group B (6 patients): Cycle 1: Pomalidomide 4 mg every day on day 1-21; Cycle 2: 2 mg every day on day 1-28; Cycle 3: 4 mg every other day on day 1-21. In Cycles of 28 days.

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Maarten R. Seefat, MD

m.seefat@amsterdamumc.nl

+31204444444

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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