Multiple MyelomaPhase 2NCT02011113
Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma
A Phase 2 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene Corporation at 14 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 14 sitesJapan
- Study dates
- Dec 2013to Sep 2015
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Must be ≥ 20 years of age at the time of signing the informed consent document.
- 2. The subject must understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.
- 3. Must be able to adhere to the study visit schedule and other protocol requirements.
- 4. Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Subjects must have received at least 2 prior therapies. Subjects must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed progressive disease(PD). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last antimyeloma drug regimen used just prior to study entry (refractory disease).
- 5. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen).
- 6. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).
- 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- 8.Must agree to comply to pomalidomide Pregnancy Prevention Risk Management Plan.
Who cannot join
- 1. Pregnant or breastfeeding females 2. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone 3. ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy 4. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study 5. Any of the following laboratory abnormalities:
- Absolute neutrophil count < 1,000/µL
- Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells
- Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
- Cockcroft-Gault estimation of Creatinine Clearance:
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
Show all 27Show fewer
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior Red blood cell transfusion or recombinant human erythropoietin use is permitted)
- Serum glutamic oxaloacetic transaminase(SGOT)/aspartate aminitransferase(AST) or serum glutamic pyruvic transaminase(SGPT)/alanine aminotransferase(ALT) > 3.0 x upper limit of normal(ULN)
- Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia.
- 6. Subjects with any one of the following:
- Congestive heart failure (New York Heart Association Class III or IV)
- Myocardial infarction within 12 months prior to starting study treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris 7. Peripheral neuropathy ≥ Grade 2. 8. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following:
- Basal or Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b) 9. Known infection with human immunodeficiency virus (HIV) antibody positive, hepatitis B virus surface antigen (HBsAg) positive or hepatitis C virus antibody (HCVAb) positive. If negative for hepatitis B virus surface antigen (HBsAg) but hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) positive status, a hepatitis B virus DNA test will be performed and if positive the subject will be excluded.
- 10. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
- 11. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- 12. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- 13. Any condition that confounds the ability to interpret data from the study. 14. Previous therapy with pomalidomide. 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment.
- 16. Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment.
- 17. Subjects who received any of the following within the last 14 days of initiation of study treatment:
- Plasmapheresis
- Major surgery (kyphoplasty is not considered major surgery)
- Radiation therapy
- Use of any antimyeloma drug therapy. 18. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
- 19. Subjects who are planning for or who are eligible for stem cell transplant.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Celgene Trial Site
Fukuoka, Fukuoka, 812-8582
Celgene Trial Site
Hiroshima, Hiroshima, 734-8551
Celgene Trial Site
Isehara, Kanagawa, 259-1193
Celgene Trial Site
Kamogawa, Chiba, 298-8602
Celgene Trial Site
Kyoto, Kyoto, 602-8566
Celgene Trial Site
Mito, Ibaragi, 311-3193
Celgene Trial Site
Nagoya, Aichi-ken, 467-8602
Celgene Trial Site
Niigata, Niigata, 951-8566
Celgene Trial Site
Okayama, Okayama-ken, 701-1192
Celgene Trial Site
Osaka, Osaka, 543-8555
Celgene Trial Site
Tokyo, Tokyo, 104-0045
Celgene Trial Site
Tokyo, Tokyo, 150-8935
Celgene Trial Site
Tokyo, Tokyo, 160-8582
Celgene Trial Site
Tokyo, Tokyo, 162-8655
About this study
Official title: A Phase 2, Multicenter, Single-arm, Open-label Study in Japan to Evaluate the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide, Dexamethasone
- Keywords
- Pomalidomide,, CC-4047,, Dexamethasone,, Relapsed and refractory multiple myeloma,, phase 2
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called CC-4047
4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle
DexamethasoneDrug
Also called LenaDex
40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide plus dexamethasone | Experimental | Not described Receives: Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Measured: From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Measured: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Secondary outcomes (9)
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria
Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.
Measured: From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks
Time to Response
Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
Measured: From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)
Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.
Measured: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Time to Response (Later Cut-off Date)
Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
Measured: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Kaplan-Meier Estimates of Duration of Response
Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.
Measured: From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks
Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)
Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.
Measured: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Kaplan-Meier Estimates of Progression-free Survival (PFS)
PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier
Measured: From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks
Kaplan-Meier Estimates of PFS (Later Cut-off Date)
PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier
Measured: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Number of Participants With Adverse Events
Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.
Measured: From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionSep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toru Sasaki, Director, Study director, Celgene K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011113
- Sponsor's protocol ID
- CC-4047-MM-011
- Status last verified
- Sep 2016
- First submitted
- 10 Dec 2013
- Last updated
- 1 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ichinohe T, Kuroda Y, Okamoto S, Matsue K, Iida S, Sunami K, Komeno T, Suzuki K, Ando K, Taniwaki M, Tobinai K, Chou T, Kaneko H, Iwasaki H, Uemura C, Tamakoshi H, Zaki MH, Doerr T, Hagiwara S. A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial. Exp Hematol Oncol. 2016 Apr 18;5:11. doi: 10.1186/s40164-016-0040-7. eCollection 2015.
PubMed 27096106
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Single-arm, Open-label Study in Japan to Evaluate the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02011113
- Acronym / sponsor ID
- CC-4047-MM-011
- Conditions
- Multiple Myeloma
- Keywords
- Pomalidomide,, CC-4047,, Dexamethasone,, Relapsed and refractory multiple myeloma,, phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Posted 10 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide plus dexamethasone | Experimental | Drug: Pomalidomide, Drug: Dexamethasone |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Must be ≥ 20 years of age at the time of signing the informed consent document.
- 2. The subject must understand and voluntarily sign an informed consent document before any study related assessments/procedures are conducted.
- 3. Must be able to adhere to the study visit schedule and other protocol requirements.
- 4. Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Subjects must have received at least 2 prior therapies. Subjects must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed progressive disease(PD). Subjects must also have documented evidence of progressive disease(PD) during or within 60 days (measured from the end of the last cycle) of completing treatment with the last antimyeloma drug regimen used just prior to study entry (refractory disease).
- 5. Subjects must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen).
Key exclusion criteria (27 listed)
- 1. Pregnant or breastfeeding females 2. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone 3. ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy 4. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study 5. Any of the following laboratory abnormalities:
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior Red blood cell transfusion or recombinant human erythropoietin use is permitted)
- Serum glutamic oxaloacetic transaminase(SGOT)/aspartate aminitransferase(AST) or serum glutamic pyruvic transaminase(SGPT)/alanine aminotransferase(ALT) > 3.0 x upper limit of normal(ULN)
- Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or ≥ 3.0 x upper limit of normal (ULN) for subjects with hereditary benign hyperbilirubinemia.
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: CC-40474 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle | Drug | Pomalidomide plus dexamethasone |
| DexamethasoneAlso: LenaDex40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle | Drug | Pomalidomide plus dexamethasone |
Primary outcome
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
Time frame: From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)
Time frame: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
9 secondary outcomes
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria
Time frame: From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks
Time to Response
Time frame: From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.
Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)
Time frame: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Time to Response (Later Cut-off Date)
Time frame: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Kaplan-Meier Estimates of Duration of Response
Time frame: From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks
Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)
Time frame: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Kaplan-Meier Estimates of Progression-free Survival (PFS)
Time frame: From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks
Kaplan-Meier Estimates of PFS (Later Cut-off Date)
Time frame: From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
Number of Participants With Adverse Events
Time frame: From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27096106Ichinohe T, Kuroda Y, Okamoto S, Matsue K, Iida S, Sunami K, Komeno T, Suzuki K, Ando K, Taniwaki M, Tobinai K, Chou T, Kaneko H, Iwasaki H, Uemura C, Tamakoshi H, Zaki MH, Doerr T, Hagiwara S. A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial. Exp Hematol Oncol. 2016 Apr 18;5:11. doi: 10.1186/s40164-016-0040-7. eCollection 2015.
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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.
Toru Sasaki, Director study director
Celgene K.K.
14 sites 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 and Dexamethasone in people with Multiple Myeloma, run by Celgene Corporation at 14 sites in Japan.
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 8 inclusion and 27 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2015). 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?
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (time frame: From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.). 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?
On the ClinicalTrials.gov record for NCT02011113, which also lists 1 linked publication.
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 1 Nov 2016.