Relapsed and/or refractorY Multiple MyelomaPhase 2PORYOUNCT03242460
The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM)
A Phase 2 study testing Pomalidomide 4 MG, Dexamethasone 20mg and Cyclophosphamide 400mg in people with Relapsed and/or refractorY Multiple Myeloma, run by Kosin University Gospel Hospital at 1 site in South Korea.
Trial summary
In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse the second-line LD when the bortezomib-containing treatment failed to salvage the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or refractorY Multiple Myeloma
- What is being tested?
- Pomalidomide 4 MG, Dexamethasone 20mg and Cyclophosphamide 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2015to 2 May 2019
- Phase
- Phase 2
- 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 must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- Serum M-protein ≥ 0.5g/dL, or
- In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
- Patients were ineligible for autologous stem cell transplantation
- Must be relapse refractory to initial therapy with bortezomib, melphalan and prednison and then lenalidomide plus dexamethasone.
- Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
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- Males and females ≥ 18 years of age or > country's legal age for adult consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
- Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.
- Calculated creatinine clearance ≥ 30mL/min or creatinine < 3mg/dL.
- Written informed consent in accordance with federal, local and institutional guidelines
Who cannot join
- Female patients who are lactating or pregnant
- Multiple Myeloma of IgM subtype
- Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
- POEMS syndrome, plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L, Waldenstrom's Macroglobulinaemia, or Patients with known amyloidosis
- Peripheral neuropathy grade > 2
- Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment
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- Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
- Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide
- Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
- Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
- Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
- Second malignancy within the past 3 years except:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Breast carcinoma in situ with full surgical resection
- Patients with steroid or lenalidomide hypersensitivity
- Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting pomalidomide treatment
- Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic university of korea, Seoul ST. Mary's Hospital.
Seoul
About this study
Official title: The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Who Had Lenalidomide Plus Dexamethasone (LD) Following Frontline Bortezomib Combined Chemotherapy, Open-labeled, Multicenter Phase II Study
In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse the second-line LD when the bortezomib-containing treatment failed to salvage the patients. Patients who have relapsed MM after exposure to the above agents and have progressive disease have a short life expectancy. Third-line therapy is needed for retrieving the patients hereafter. And substantial proportion of patients will attain an advanced age. To examine if time to disease progression is maintained and tolerability is improved with lower dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is achieved after 3 months of treatment with the initial dose. Three months later (6 months after the initial treatment), the response remains in stable disease, 2nd dose reduction (dexamethasone 10mg or prednisone 50mg) will be carried out.
- Being tested
- Pomalidomide 4 MG, Dexamethasone 20mg, Cyclophosphamide 400mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide 4 MGDrug
Also called pomalyst
Pomalidomide 4mg Days 1-21
Dexamethasone 20mgDrug
Dexamethasone 20mg Days 1, 8, 15, 22
Cyclophosphamide 400mgDrug
Cyclophosphamide 400mg Days 1, 8, 15
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide, Dexamethasone, Cyclophosphamide | Experimental | Pomalidomide 4mg Days 1-21 Dexamethasone 20mg Days 1, 8, 15, 22 Cyclophosphamide 400mg Days 1, 8, 15 Receives: Drug: Pomalidomide 4 MG; Drug: Dexamethasone 20mg; Drug: Cyclophosphamide 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-free Survival (PFS)
Kaplan-Meier method
Measured: 2 years follow up
Secondary outcomes (3)
Objective Response Rate (ORR)
International Myeloma Working Group,( IMWG)
Measured: 2 years follow up
Overall survival (OS)
Kaplan-Meier method
Measured: 2 years follow up
Safety evaluations assessed using Common Terminology Criteria for Adverse Events v4.0
Common Terminology Criteria for Adverse Events v4.0
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start12 May 2015
- Primary completion24 Apr 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or refractorY 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- the transplant-ineligible patients with Relapsed and/or refractorY multiple myeloma (MM) who had lenalidomide+dexamethasone (LD) following frontline bortezomib combined chemotherapy
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sup Lee, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242460
- Sponsor's protocol ID
- PORYOU
- Acronym
- PORYOU
- Status last verified
- Feb 2020
- First submitted
- 1 Aug 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: KMMWP
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Who Had Lenalidomide Plus Dexamethasone (LD) Following Frontline Bortezomib Combined Chemotherapy, Open-labeled, Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT03242460
- Acronym / sponsor ID
- PORYOU / PORYOU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Study start
- 12 May 2015
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 8 Aug 2017 (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.
In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse the second-line LD when the bortezomib-containing treatment failed to salvage the patients. Patients who have relapsed MM after exposure to the above agents and have progressive disease have a short life expectancy. Third-line therapy is needed for retrieving the patients hereafter. And substantial proportion of patients will attain an advanced age. To examine if time to disease progression is maintained and tolerability is improved with lower dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is achieved after 3 months of treatment with the initial dose. Three months later (6 months after the initial treatment), the response remains in stable disease, 2nd dose reduction (dexamethasone 10mg or prednisone 50mg) will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the transplant-ineligible patients with Relapsed and/or refractorY multiple myeloma (MM) who had lenalidomide+dexamethasone (LD) following frontline bortezomib combined chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide, Dexamethasone, Cyclophosphamide | Experimental | Drug: Pomalidomide 4 MG, Drug: Dexamethasone 20mg, Drug: Cyclophosphamide 400mgPomalidomide 4mg Days 1-21 Dexamethasone 20mg Days 1, 8, 15, 22 Cyclophosphamide 400mg Days 1, 8, 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- Patients were ineligible for autologous stem cell transplantation
- Must be relapse refractory to initial therapy with bortezomib, melphalan and prednison and then lenalidomide plus dexamethasone.
- Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
- Males and females ≥ 18 years of age or > country's legal age for adult consent
Key exclusion criteria (18 listed)
- Female patients who are lactating or pregnant
- Multiple Myeloma of IgM subtype
- Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
- POEMS syndrome, plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L, Waldenstrom's Macroglobulinaemia, or Patients with known amyloidosis
- Peripheral neuropathy grade > 2
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 MGAlso: pomalystPomalidomide 4mg Days 1-21 | Drug | Pomalidomide, Dexamethasone, Cyclophosphamide |
| Dexamethasone 20mgDexamethasone 20mg Days 1, 8, 15, 22 | Drug | Pomalidomide, Dexamethasone, Cyclophosphamide |
| Cyclophosphamide 400mgCyclophosphamide 400mg Days 1, 8, 15 | Drug | Pomalidomide, Dexamethasone, Cyclophosphamide |
Primary outcome
Median Progression-free Survival (PFS)
Time frame: 2 years follow up
Kaplan-Meier method
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years follow up
Overall survival (OS)
Time frame: 2 years follow up
Safety evaluations assessed using Common Terminology Criteria for Adverse Events v4.0
Time frame: 2 years follow up
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 20 Feb 2020.
- Individual participant dataSharing planned: Undecided. KMMWP
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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 2 study testing Pomalidomide 4 MG, Dexamethasone 20mg and Cyclophosphamide 400mg in people with Relapsed and/or refractorY Multiple Myeloma, run by Kosin University Gospel Hospital at 1 site in South Korea.
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 13 inclusion and 18 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 20 Feb 2020. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Median Progression-free Survival (PFS) (time frame: 2 years follow up). 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 20 Feb 2020.