Multiple Myeloma in RelapsePhase 4POMAlternativeNCT05555329
Alternative Dosing Scheme of Pomalidomide 4 mg Every Other Day Versus Pomalidomide 2 mg and 4 mg Every Day; the POMAlternative Study
A Phase 4 study testing Pomalidomide 4 mg every day in cycle 1, Pomalidomide 4 mg every other day in cycle 2 and Pomalidomide 2 mg every day in cycle 2 in people with Multiple Myeloma in Relapse and Multiple Myeloma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma, Refractory
- What is being tested?
- Pomalidomide 4 mg every day in cycle 1, Pomalidomide 4 mg every other day in cycle 2 and Pomalidomide 2 mg every day in cycle 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 14 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed 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.
- Being tested
- Pomalidomide 4 mg every day in cycle 1, Pomalidomide 4 mg every other day in cycle 2, Pomalidomide 2 mg every day in cycle 2, Pomalidomide 2 mg every day in cycle 3, Pomalidomide 4 mg every other day in cycle 3
- Keywords
- Multiple myeloma, Pomalidomide, Pharmacokinetics/dynamics, Cost-effectiveness
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide 4 mg every day in cycle 1Drug
Also called Cycle 1
Pomalidomide 4 mg every day, on days 1-21 in a cycle of 28 days
Pomalidomide 4 mg every other day in cycle 2Drug
Also called Cycle 2 (Group A)
Pomalidomide 4 mg every other day, on days 1-21 in a cycle of 28 days
Pomalidomide 2 mg every day in cycle 2Drug
Also called Cycle 2 (Group B)
Pomalidomide 2 mg every day, on days 1-28 in a cycle of 28 days
Pomalidomide 2 mg every day in cycle 3Drug
Also called Cycle 3 (Group A)
Pomalidomide 2 mg every day, on days 1-28 in a cycle of 28 days
Pomalidomide 4 mg every other day in cycle 3Drug
Also called Cycle 3 (Group B)
Pomalidomide 4 mg every other day, on days 1-21 in a cycle of 28 days
| Study group | Role | What they receive |
|---|---|---|
| Group A; Pomalidomide 4 mg every other day in cycle 2 | Experimental | 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. Receives: Drug: Pomalidomide 4 mg every day in cycle 1; Drug: Pomalidomide 4 mg every other day in cycle 2; Drug: Pomalidomide 2 mg every day in cycle 3 |
| Group B; Pomalidomide 4 mg every other day in cycle 3 | Experimental | 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. Receives: Drug: Pomalidomide 4 mg every day in cycle 1; Drug: Pomalidomide 2 mg every day in cycle 2; Drug: Pomalidomide 4 mg every other day in cycle 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The AUC/MIC ratio
The AUC/MIC ratio 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.
Measured: During three cycles of 28 days
The level of the Ctrough
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.
Measured: During three cycles of 28 days
Secondary outcomes (4)
Cmax
The Cmax 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.
Measured: During three cycles of 28 days
Time above EC50
The time above the 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.
Measured: During three cycles of 28 days
Toxicity and side effects
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.
Measured: During three cycles of 28 days
Overall response rate (ORR)
Overall response rate (ORR), based on the IMWG criteria
Measured: During three cycles of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Dec 2022
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonja Zweegman, Amsterdam UMC, location VUmc
- Investigators
- Sonja Zweegman, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555329
- Sponsor's protocol ID
- POMAlternative
- Acronym
- POMAlternative
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2022
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05555329
- Acronym / sponsor ID
- POMAlternative / POMAlternative
- Keywords
- Multiple myeloma, Pomalidomide, Pharmacokinetics/dynamics, Cost-effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A; Pomalidomide 4 mg every other day in cycle 2 | Experimental | Drug: Pomalidomide 4 mg every day in cycle 1, Drug: Pomalidomide 4 mg every other day in cycle 2, Drug: Pomalidomide 2 mg every day in cycle 3Group 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. |
| Group B; Pomalidomide 4 mg every other day in cycle 3 | Experimental | Drug: Pomalidomide 4 mg every day in cycle 1, Drug: Pomalidomide 2 mg every day in cycle 2, Drug: Pomalidomide 4 mg every other day in cycle 3Group 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomalidomide 4 mg every day in cycle 1Also: Cycle 1Pomalidomide 4 mg every day, on days 1-21 in a cycle of 28 days | Drug | Group A; Pomalidomide 4 mg every other day in cycle 2, Group B; Pomalidomide 4 mg every other day in cycle 3 |
| Pomalidomide 4 mg every other day in cycle 2Also: Cycle 2 (Group A)Pomalidomide 4 mg every other day, on days 1-21 in a cycle of 28 days | Drug | Group A; Pomalidomide 4 mg every other day in cycle 2 |
| Pomalidomide 2 mg every day in cycle 2Also: Cycle 2 (Group B)Pomalidomide 2 mg every day, on days 1-28 in a cycle of 28 days | Drug | Group B; Pomalidomide 4 mg every other day in cycle 3 |
| Pomalidomide 2 mg every day in cycle 3Also: Cycle 3 (Group A)Pomalidomide 2 mg every day, on days 1-28 in a cycle of 28 days | Drug | Group A; Pomalidomide 4 mg every other day in cycle 2 |
| Pomalidomide 4 mg every other day in cycle 3Also: Cycle 3 (Group B)Pomalidomide 4 mg every other day, on days 1-21 in a cycle of 28 days | Drug | Group B; Pomalidomide 4 mg every other day in cycle 3 |
Primary outcome
The AUC/MIC ratio
Time frame: During three cycles of 28 days
The AUC/MIC ratio 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.
The level of the Ctrough
Time frame: During three cycles of 28 days
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.
4 secondary outcomes
Cmax
Time frame: During three cycles of 28 days
Time above EC50
Time frame: During three cycles of 28 days
Toxicity and side effects
Time frame: During three cycles of 28 days
Overall response rate (ORR)
Time frame: During three cycles of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Zweegman, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pomalidomide 4 mg every day in cycle 1, Pomalidomide 4 mg every other day in cycle 2 and Pomalidomide 2 mg every day in cycle 2 in people with Multiple Myeloma in Relapse and Multiple Myeloma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The AUC/MIC ratio (time frame: During three cycles of 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.