Multiple MyelomaPhase 3PO-3887NCT03440411
Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment
A Phase 3 study testing Pomalidomide, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
Trial summary
The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for Multiple Myeloma (MM) patients, both at diagnosis and at relapse. Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to improve the efficacy and reduce the toxicity of the parent molecule. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Pomalidomide, Cyclophosphamide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2016to 31 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years and <80 years.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Male patient agrees to use an acceptable method for contraception (i.e. condom or abstinence) for the duration of the study.
- Female of childbearing potential agrees to use two acceptable methods for contraception [implant, levonorgestrel-releasing intrauterine system (IUS), medroxyprogesterone acetate depot, tubal sterilization, sexual intercourse with a vasectomised male partner only (vasectomy must be confirmed by two negative semen analyses), ovulation inhibitory progesterone-only pills (i.e. desogestrel)] or absolute and continuous sexual abstinence.
- Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved Free Light Chain (FLC) levels must be > 10 mg/dL. Less than 10% of oligo- or non-secretory MM patients with free light chains will be admitted to this study in order to maximize interpretation of benefit results.
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- Patient receiving lenalidomide maintenance therapy as part of first line treatment (concomitant use of prednisone is accepted) and has experienced a biochemical relapse, with evidence of progressive disease defined as an increase of 25% from lowest response value in any one or more of the following: serum M-component (absolute increase must be ≥0.5 g/100 ml) and/or urine M-component (absolute increase must be ≥200 mg per 24 hours) only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels must be >10 mg/dL (35).
- Patient who received as first line treatment a bortezomib-based therapy, including lenalidomide maintenance during the same line of therapy, can be included in the trial.
- Patient has a life-expectancy > 3 months
- Patient has not a currently active malignancy, other than non melanoma skin cancer and carcinoma in situ of the cervix, and has not invasive malignancies within the past 5 years.
- No history of allergic reactions attributed to study agents
- Patient has the following laboratory values within 28 days before baseline day 1 of the cycle 1:
- absolute neutrophil count (ANC) > 1 x 10^9/L
- platelet count > 75 x 10^9/L
- haemoglobin > 8 g/dl.
- aspartate transaminase (AST): < 2 x the upper limit of normal (ULN).
- alanine transaminase (ALT): < 2 x the ULN.
Who cannot join
- Pregnant or lactating females.
- Patient with Creatinine Clearance (CrCl) < 45 mL/minute
- Patient with peripheral neuropathy ≥ Grade 2
- Subject with any one of the following:
- Congestive heart failure (NY Heart Association Class III or IV)
- Myocardial infarction within 12 months prior to starting study treatment
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- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- Any significant medical disease or conditions (e.g. pulmonary disease, infection) that, in the investigator's opinion, may interfere with protocol adherence or subject's ability to give informed consent or could place the subject at unacceptable risk.
- Clinical active infectious hepatitis type A, B, C or HIV Acute active infection requiring antibiotics or infiltrative pulmonary disease
- Contraindication to any of the required drugs or supportive treatments.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A MULTICENTER, OPEN LABEL, RANDOMIZED PHASE III STUDY OF POMALIDOMIDE-DEXAMETHASONE vs POMALIDOMIDE-CYCLOPHOSPHAMIDE-DEXAMETHASONE IN MULTIPLE MYELOMA (MM) PATIENTS WHO EXPERIENCE BIOCHEMICAL OR CLINICAL RELAPSE DURING LENALIDOMIDE MAINTENANCE TREATMENT
The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for Multiple Myeloma (MM) patients, both at diagnosis and at relapse.
Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to improve the efficacy and reduce the toxicity of the parent molecule. Pomalidomide and dexamethasone (pom-dex) proved to be an effective and safe treatment in MM patients refractory to lenalidomide and refractory/intolerant to bortezomib.
Read more
The addition of chemotherapy to novel drugs has been evaluated both at diagnosis and at relapse. The combination of pomalidomide-cyclophosphamide-prednisone proved to be safe and effective in relapsed/refractory MM patients. The combination pomalidomide-cyclophosphamide-dexamethasone (pom-cyclo-dex) was tested in a phase II study in patients with relapsed and refractory MM, demonstrating a good tolerability using pomalidomide at the dose of 4 mg. Pom-cyclo-dex resulted in a superior response rate and Progression-Free Survival (PFS) compared to pom-dex. The increased hematologic toxicities, as a result of the addition of oral cyclophosphamide, were manageable. With an overall response rate of 65% the combination demonstrated a promising efficacy.The first aim of our trial, is to compare the combination of pom-cyclo-dex vs pom-dex.
Relapsed myeloma is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy.
According to International Myeloma Working Group (IMWG) recommendation, biochemical relapse is defined as an increase of ≥ 25% of tumor burden from lowest value, without any CRAB feature (CRAB is defined as the onset of clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) and detected in 2 consecutive determinations.
Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features).
Treatment at relapse should start in case of clinical relapse or a significant paraprotein increase (doubling of M-component in 2 months).
In case of biochemical relapse the standard is observation only, as in case of asymptomatic MM at diagnosis.
However, a recently published trial, showed improved PFS and OS for newly diagnosed asymptomatic patients treated with lenalidomide and dexamethasone in comparison with observation only. Our hypothesis is that similarly, in the relapse setting, patients may benefit from an early intervention, meaning a treatment at biochemical relapse and not only in case of clinical relapse or rapid increase of M-component.
Read the detailed description
Multiple myeloma (MM) is a neoplastic disease of older adults, with a higher incidence in elderly patients: 26% are aged 65-74 years, and 37% are older than 75 years. The annual prevalence of MM is approximately 31 cases per 100,000 people in patients aged 65-74 years, and it increases to 46 cases per 100,000 people in patients aged ≥75 years. The prevalence of myeloma is likely to increase due to the extended survival and the growing life expectancy of the general population.
Recently, the introduction of novel agents such as thalidomide, lenalidomide, pomalidomide and bortezomib, has changed the treatment paradigm of MM and extended survival.
The prognosis of patients who are refractory to novel agents is especially poor. A retrospective study has recently demonstrated that patients with relapsed MM, who were refractory to bortezomib and were relapsed following, refractory to or ineligible to receive treatment with an IMiD, had a median overall survival (OS) and event free survival (EFS) of 9 and 5 months, respectively.
STUDY DESIGN When patients experience biochemical relapse during lenalidomide maintenance, they will stop lenalidomide, as established in the related experimental protocol. Afterwards, patients can be considered for the enrollment in the present study if all inclusion and exclusion criteria are met.
This is a multicenter, randomized, open label phase III study designed to assess the safety and the efficacy of two different pomalidomide combinations as salvage treatment in multiple myeloma (MM) patients.
Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).
The pre-treatment period includes screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above.
The treatment period includes administration of pomalidomide and dexamethasone in arm A and pomalidomide combined with cyclophosphamide and dexamethasone in arm B. The response will be assessed after each cycle. Patients will be randomized to receive treatment at biochemical relapse (ARM I) or at clinical relapse (ARM II).
The LTFU periods will start after development of confirmed progression disease (PD), all patients are to be followed for survival during the LTFU period every 3 months via telephone or office visit.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide, Cyclophosphamide, Dexamethasone
- Keywords
- biochemical relapse
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called Imnovid(R)
4 mg/daily as oral administration (PO) on days 1-21.
CyclophosphamideDrug
Also called Endoxan(R)
50 mg every other day as oral administration (PO) on days 1-28
DexamethasoneDrug
Also called Soldesam(R)
40 mg as oral administration (PO) on days 1, 8, 15, 22.
| Study group | Role | What they receive |
|---|---|---|
| ARM pom-dex Early (A-I) | Active comparator | Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/day on days 1-21 Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance Receives: Drug: Pomalidomide; Drug: Dexamethasone |
| ARM pom-cyclo-dex Early(B-I) | Experimental | Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/day on days 1-21 Cyclophosphamide: 50 mg every other day Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance Receives: Drug: Pomalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone |
| ARM pom-dex Late (A-II) | Experimental | Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/day on days 1-21 Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance Receives: Drug: Pomalidomide; Drug: Dexamethasone |
| ARM pom-cyclo-dex Late (B-II) | Active comparator | Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.
Pomalidomide: 4 mg/day on days 1-21 Cyclophosphamide: 50 mg every other day Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance Receives: Drug: Pomalidomide; Drug: Cyclophosphamide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons B vs A
Measured: 57 months
Overall Survival
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons II vs I
Measured: 57 months
Secondary outcomes (9)
Clinical Progression
defined as the time from random assignment to the early or late strategy to the date of onset of CRAB symptoms or death.
Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features). Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder:
- hypercalcaemia
- renal insufficiency
- anaemia
- bone lesions
Any one or more of the following biomarkers of malignancy:
- clonal bone marrow plasma cell percentage ≥60%
- involved:uninvolved serum free light chain ratio ≥100
- >1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
Progresson was defined accoring to IMWG criteria as reported before
Measured: 57 months
Progression Free-survival (PFS)
PFS for the comparison B vs A will be measured from the date of randomization disclosure to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to Follow Up (FU) will also be censored at the time of last complete disease assessment
Measured: 57 months
Progression Free Survival (PFS)
PFS for the comparison II vs I will be measured from the date of randomization disclosure to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Measured: 57 months
Progression Free-survival 2(PFS2)
PFS for the comparison B vs A will be measured from the date of randomization disclosure to the date of first observation of PD in second line therapy, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Measured: 57 months
Progression Free Survival 2(PFS2)
PFS for the comparison II vs I will be measured from the date of randomization disclosure to the date of first observation of PD in second line therapy, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
Measured: 57 months
Objective Overall Response Rate for the Comparison B vs A
in terms of partial response (PR), very good partial response (VGPR), complete response (CR).and stringent complete response (sCR) according to IMWG response crieria (https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple).
Measured: 57 months
Objective Overall Response Rate for the Comparison II vs I
in terms of partial response (PR), very good partial response (VGPR), complete response (CR).and stringent complete response (sCR) according to IMWG response crieria (https://www.myeloma.org/resource-library/international-myeloma-working-group-imwg-uniform-response-criteria-multiple).
Measured: 57 months
Quality of Life Questionnaire (QLQ) With EORTC-QLQ-C30
outcome will be measured with EORTC-QLQ-C30 at baseline, every 2 months during the first year, and then every 6 months for the comparison B vs B and I vs II.
Measured: 57 months
Quality of Life With QLQ-MY(Myeloma)24
outcome will be measured with QLQ-MY24 at baseline, every 2 months during the first year, and then every 6 months for the comparison B vs B and I vs II.
Measured: 57 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start18 Feb 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2x2 factorial randomized study.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione EMN Italy Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440411
- Sponsor's protocol ID
- PO-CL-MM-PI-003887
- Acronym
- PO-3887
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2018
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTER, OPEN LABEL, RANDOMIZED PHASE III STUDY OF POMALIDOMIDE-DEXAMETHASONE vs POMALIDOMIDE-CYCLOPHOSPHAMIDE-DEXAMETHASONE IN MULTIPLE MYELOMA (MM) PATIENTS WHO EXPERIENCE BIOCHEMICAL OR CLINICAL RELAPSE DURING LENALIDOMIDE MAINTENANCE TREATMENT
- ClinicalTrials.gov ID
- NCT03440411
- Acronym / sponsor ID
- PO-3887 / PO-CL-MM-PI-003887
- Conditions
- Multiple Myeloma
- Keywords
- biochemical relapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Fondazione EMN Italy OnlusUniversity, hospital or other
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combination lenalidomide plus low-dose dexamethasone (Rd) is an active treatment for Multiple Myeloma (MM) patients, both at diagnosis and at relapse.
Pomalidomide, is an immunomodulatory molecule (IMID), derivative of thalidomide, developed to improve the efficacy and reduce the toxicity of the parent molecule. Pomalidomide and dexamethasone (pom-dex) proved to be an effective and safe treatment in MM patients refractory to lenalidomide and refractory/intolerant to bortezomib.
The addition of chemotherapy to novel drugs has been evaluated both at diagnosis and at relapse. The combination of pomalidomide-cyclophosphamide-prednisone proved to be safe and effective in relapsed/refractory MM patients. The combination pomalidomide-cyclophosphamide-dexamethasone (pom-cyclo-dex) was tested in a phase II study in patients with relapsed and refractory MM, demonstrating a good tolerability using pomalidomide at the dose of 4 mg. Pom-cyclo-dex resulted in a superior response rate and Progression-Free Survival (PFS) compared to pom-dex. The increased hematologic toxicities, as a result of the addition of oral cyclophosphamide, were manageable. With an overall response rate of 65% the combination demonstrated a promising efficacy.The first aim of our trial, is to compare the combination of pom-cyclo-dex vs pom-dex.
Relapsed myeloma is defined as previously treated myeloma that progresses and requires the initiation of salvage therapy.
According to International Myeloma Working Group (IMWG) recommendation, biochemical relapse is defined as an increase of ≥ 25% of tumor burden from lowest value, without any CRAB feature (CRAB is defined as the onset of clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) and detected in 2 consecutive determinations.
Clinical relapse requires one or more direct indicators of progressive disease and end organ dysfunction (CRAB features).
Treatment at relapse should start in case of clinical relapse or a significant paraprotein increase (doubling of M-component in 2 months).
In case of biochemical relapse the standard is observation only, as in case of asymptomatic MM at diagnosis.
However, a recently published trial, showed improved PFS and OS for newly diagnosed asymptomatic patients treated with lenalidomide and dexamethasone in comparison with observation only. Our hypothesis is that similarly, in the relapse setting, patients may benefit from an early intervention, meaning a treatment at biochemical relapse and not only in case of clinical relapse or rapid increase of M-component.
Detailed description
Multiple myeloma (MM) is a neoplastic disease of older adults, with a higher incidence in elderly patients: 26% are aged 65-74 years, and 37% are older than 75 years. The annual prevalence of MM is approximately 31 cases per 100,000 people in patients aged 65-74 years, and it increases to 46 cases per 100,000 people in patients aged ≥75 years. The prevalence of myeloma is likely to increase due to the extended survival and the growing life expectancy of the general population.
Recently, the introduction of novel agents such as thalidomide, lenalidomide, pomalidomide and bortezomib, has changed the treatment paradigm of MM and extended survival.
The prognosis of patients who are refractory to novel agents is especially poor. A retrospective study has recently demonstrated that patients with relapsed MM, who were refractory to bortezomib and were relapsed following, refractory to or ineligible to receive treatment with an IMiD, had a median overall survival (OS) and event free survival (EFS) of 9 and 5 months, respectively.
STUDY DESIGN When patients experience biochemical relapse during lenalidomide maintenance, they will stop lenalidomide, as established in the related experimental protocol. Afterwards, patients can be considered for the enrollment in the present study if all inclusion and exclusion criteria are met.
This is a multicenter, randomized, open label phase III study designed to assess the safety and the efficacy of two different pomalidomide combinations as salvage treatment in multiple myeloma (MM) patients.
Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).
The pre-treatment period includes screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above.
The treatment period includes administration of pomalidomide and dexamethasone in arm A and pomalidomide combined with cyclophosphamide and dexamethasone in arm B. The response will be assessed after each cycle. Patients will be randomized to receive treatment at biochemical relapse (ARM I) or at clinical relapse (ARM II).
The LTFU periods will start after development of confirmed progression disease (PD), all patients are to be followed for survival during the LTFU period every 3 months via telephone or office visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a 2x2 factorial randomized study.
| Arm | Type | Receives |
|---|---|---|
| ARM pom-dex Early (A-I) | Active comparator | Drug: Pomalidomide, Drug: DexamethasonePatients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/day on days 1-21 Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance |
| ARM pom-cyclo-dex Early(B-I) | Experimental | Drug: Pomalidomide, Drug: Cyclophosphamide, Drug: DexamethasonePatients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/day on days 1-21 Cyclophosphamide: 50 mg every other day Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance |
| ARM pom-dex Late (A-II) | Experimental | Drug: Pomalidomide, Drug: DexamethasonePatients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/day on days 1-21 Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance |
| ARM pom-cyclo-dex Late (B-II) | Active comparator | Drug: Pomalidomide, Drug: Cyclophosphamide, Drug: DexamethasonePatients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/day on days 1-21 Cyclophosphamide: 50 mg every other day Dexamethasone: 40 mg on days 1, 8, 15, 22 For 28-day cycles until progression or intolerance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients >18 years and <80 years.
- Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Male patient agrees to use an acceptable method for contraception (i.e. condom or abstinence) for the duration of the study.
- Female of childbearing potential agrees to use two acceptable methods for contraception [implant, levonorgestrel-releasing intrauterine system (IUS), medroxyprogesterone acetate depot, tubal sterilization, sexual intercourse with a vasectomised male partner only (vasectomy must be confirmed by two negative semen analyses), ovulation inhibitory progesterone-only pills (i.e. desogestrel)] or absolute and continuous sexual abstinence.
Key exclusion criteria (11 listed)
- Pregnant or lactating females.
- Patient with Creatinine Clearance (CrCl) < 45 mL/minute
- Patient with peripheral neuropathy ≥ Grade 2
- Subject with any one of the following:
- Congestive heart failure (NY Heart Association Class III or IV)
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 |
|---|---|---|
| PomalidomideAlso: Imnovid(R)4 mg/daily as oral administration (PO) on days 1-21. | Drug | ARM pom-cyclo-dex Early(B-I), ARM pom-cyclo-dex Late (B-II), ARM pom-dex Early (A-I), ARM pom-dex Late (A-II) |
| CyclophosphamideAlso: Endoxan(R)50 mg every other day as oral administration (PO) on days 1-28 | Drug | ARM pom-cyclo-dex Early(B-I), ARM pom-cyclo-dex Late (B-II) |
| DexamethasoneAlso: Soldesam(R)40 mg as oral administration (PO) on days 1, 8, 15, 22. | Drug | ARM pom-cyclo-dex Early(B-I), ARM pom-cyclo-dex Late (B-II), ARM pom-dex Early (A-I), ARM pom-dex Late (A-II) |
Primary outcome
Overall Survival (OS)
Time frame: 57 months
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons B vs A
Overall Survival
Time frame: 57 months
defined as the time from the date of random disclosure to the date of death from any cause for the comparisons II vs I
9 secondary outcomes
Clinical Progression
Time frame: 57 months
Progression Free-survival (PFS)
Time frame: 57 months
Progression Free Survival (PFS)
Time frame: 57 months
Progression Free-survival 2(PFS2)
Time frame: 57 months
Progression Free Survival 2(PFS2)
Time frame: 57 months
Objective Overall Response Rate for the Comparison B vs A
Time frame: 57 months
Objective Overall Response Rate for the Comparison II vs I
Time frame: 57 months
Quality of Life Questionnaire (QLQ) With EORTC-QLQ-C30
Time frame: 57 months
Quality of Life With QLQ-MY(Myeloma)24
Time frame: 57 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pomalidomide, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.
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 17 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: stopped early, as of the sponsor's last update on 10 Mar 2021. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (OS) (time frame: 57 months). 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 10 Mar 2021.