Clinical Trials List
Protocol Number2012-005
2013-09-01 - 2016-06-21
Phase III
Terminated5
Study ended1
ICD-10C90.01
Multiple myeloma in remission
ICD-10C90.00
Multiple myeloma not having achieved remission
ICD-9203.01
Multiple myeloma, in remission
ICD-9203.00
Multiple myeloma, without mention of remission
A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma
-
Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Onyx Therapeutics, Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ching-Chan Lin Division of Hematology & Oncology
- Chen-Yuan Lin Division of Hematology & Oncology
- 林柏翰 Division of Hematology & Oncology
- Li-Yuan Bai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
2 Study ended
Condition/Disease
Multiple Myeloma
Objectives
Primary Objective:
To compare the progression-free survival (PFS) of transplant-ineligible
subjects with newly diagnosed multiple myeloma who are treated with
carfilzomib, melphalan, and prednisone (CMP) versus those treated
with bortezomib (Velcade), melphalan, and prednisone (VMP).
Test Drug
Carfilzomib
Active Ingredient
Carfilzomib
Dosage Form
lyophilized powder for solution for injection/vial
Dosage
60 mg /vial
Endpoints
Primary Endpoint:
The primary endpoint is PFS.
Secondary Endpoints:
The secondary endpoints are:
OS
CR status
OR status
DOR
Neuropathy Events
Change from baseline in HRQOL score using EORTC QLQ-C30
Global Health Status scale
The primary endpoint is PFS.
Secondary Endpoints:
The secondary endpoints are:
OS
CR status
OR status
DOR
Neuropathy Events
Change from baseline in HRQOL score using EORTC QLQ-C30
Global Health Status scale
Inclution Criteria
1. Newly diagnosed symptomatic multiple myeloma
2. Transplant-ineligibility
3. Measurable disease, as defined by one or more of the following
(assessed within 21 days prior to randomization):
Serum M-protein ≥ 0.5 g/dL, or
Urine M-protein ≥ 200 mg/24 hours, or
In subjects without detectable serum or urine M-protein, serum
free light chain (SFLC) > 100 mg/L (involved light chain) and
an abnormal / ratio
4. No prior treatment for multiple myeloma
5. Males and females ≥ 18 years of age
6. Eastern Cooperative Oncology Group (ECOG) performance status
0–2
7. Adequate hepatic function within 21 days prior to randomization,
with bilirubin < 1.5 times the upper limit of normal (ULN), and
aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) < 3 times the ULN
8. Absolute neutrophil count (ANC) ≥ 1.0 × 109
/L
9. Hemoglobin (Hgb) ≥ 8.0 g/dL within 21 days prior to
randomization. Use of erythropoietic stimulating factors and red
blood cell (RBC) transfusions per institutional guidelines is
allowed.
10. Platelet count ≥ 50 × 109
/L
11. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min
within 21 days prior to randomization. Calculation should be based
on the Cockcroft and Gault formula:
[(140 – Age) Mass (kg) / (72 Creatinine mg/dL)];
multiply result by 0.85 if female.
12. Left ventricular ejection fraction (LVEF) ≥ 40%; 2-d transthoracic
echocardiogram (ECHO) is the preferred method of evaluation;
multiple gated acquisition scan (MUGA) is acceptable if ECHO is
not available
13. Females of child-bearing potential (FCBP) must have a confirmed
negative serum pregnancy test within 21 days prior to
randomization (performed at central laboratory) and agree to use an
effective method of contraception during and for 6 months
following the last dose of all study drugs (more frequent pregnancy
tests may be conducted if required by local regulations). This
protocol defines a FCBP as a sexually mature woman who:
1) has not undergone a hysterectomy or bilateral oophorectomy, or
2) has not been naturally postmenopausal for at least
24 consecutive months (i.e., has had menses at any time in the
preceding 24 consecutive months).
14. Male subjects must use an effective barrier method of contraception
during study and for 6 months following the last dose of all study
drugs if sexually active with a female of child-bearing potential.
15. Written informed consent in accordance with federal, local, and
institutional guidelines
2. Transplant-ineligibility
3. Measurable disease, as defined by one or more of the following
(assessed within 21 days prior to randomization):
Serum M-protein ≥ 0.5 g/dL, or
Urine M-protein ≥ 200 mg/24 hours, or
In subjects without detectable serum or urine M-protein, serum
free light chain (SFLC) > 100 mg/L (involved light chain) and
an abnormal / ratio
4. No prior treatment for multiple myeloma
5. Males and females ≥ 18 years of age
6. Eastern Cooperative Oncology Group (ECOG) performance status
0–2
7. Adequate hepatic function within 21 days prior to randomization,
with bilirubin < 1.5 times the upper limit of normal (ULN), and
aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) < 3 times the ULN
8. Absolute neutrophil count (ANC) ≥ 1.0 × 109
/L
9. Hemoglobin (Hgb) ≥ 8.0 g/dL within 21 days prior to
randomization. Use of erythropoietic stimulating factors and red
blood cell (RBC) transfusions per institutional guidelines is
allowed.
10. Platelet count ≥ 50 × 109
/L
11. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min
within 21 days prior to randomization. Calculation should be based
on the Cockcroft and Gault formula:
[(140 – Age) Mass (kg) / (72 Creatinine mg/dL)];
multiply result by 0.85 if female.
12. Left ventricular ejection fraction (LVEF) ≥ 40%; 2-d transthoracic
echocardiogram (ECHO) is the preferred method of evaluation;
multiple gated acquisition scan (MUGA) is acceptable if ECHO is
not available
13. Females of child-bearing potential (FCBP) must have a confirmed
negative serum pregnancy test within 21 days prior to
randomization (performed at central laboratory) and agree to use an
effective method of contraception during and for 6 months
following the last dose of all study drugs (more frequent pregnancy
tests may be conducted if required by local regulations). This
protocol defines a FCBP as a sexually mature woman who:
1) has not undergone a hysterectomy or bilateral oophorectomy, or
2) has not been naturally postmenopausal for at least
24 consecutive months (i.e., has had menses at any time in the
preceding 24 consecutive months).
14. Male subjects must use an effective barrier method of contraception
during study and for 6 months following the last dose of all study
drugs if sexually active with a female of child-bearing potential.
15. Written informed consent in accordance with federal, local, and
institutional guidelines
Exclusion Criteria
1. Multiple Myeloma of IgM subtype
2. Glucocorticoid therapy within 14 days prior to randomization that
equals or exceeds a cumulative dose of 160 mg of dexamethasone
3. POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)
4. Plasma cell leukemia (> 2.0 × 109
/L circulating plasma cells by
standard differential)
5. Waldenström macroglobulinemia (WM)
6. Known amyloidosis
7. Focal radiation therapy within 7 days prior to randomization
8. Any immunotherapy within 21 days prior to randomization
9. Major surgery within 21 days prior to randomization
10. Active congestive heart failure (New York Heart Association
[NYHA] Class III to IV), symptomatic ischemia, conduction
abnormalities uncontrolled by conventional intervention, acute
diffuse infiltrative pulmonary disease, pericardial disease, or
myocardial infarction within 6 months prior to randomization.
11. Active infection within 14 days prior to randomization
12. Known human immunodeficiency virus (HIV) seropositive,
hepatitis C infection, and/or hepatitis B (subjects with hepatitis B
surface antigen [SAg] or core antibody receiving and responding to
antiviral therapy directed at hepatitis B are allowed)
13. Known cirrhosis
14. Second malignancy within the past 5 years except:
Adequately treated basal cell or squamous cell skin cancer,
Carcinoma in situ of the cervix, or
Prostate cancer < Gleason score 6 with undetectable prostatespecific antigen (PSA) over 12 months, or
Ductal breast carcinoma in situ with full surgical resection (i.e.,
negative margins), or
Treated medullary or papillary thyroid cancer, or
Similar condition with an expectation of >95 % 5-year disease
free survival
15. Myelodysplastic syndrome
16. Significant neuropathy (Grades ≥ 2) within 14 days prior to
randomization
17. Female subjects who are pregnant or lactating
18. Known history of allergy to Captisol (a cyclodextrin derivative
used to solubilize carfilzomib)
19. Hypersensitivity to boron, or mannitol (associated with bortezomib
administration)
20. Hypersensitivity to melphalan or to any of the excipients of
Alkeran
21. Contraindication to prednisone or dexamethasone
22. Contraindication to any of the required concomitant drugs or
supportive treatments, including hypersensitivity to antiviral drugs,
or intolerance to hydration due to preexisting pulmonary or cardiac
impairment
23. Pleural effusions requiring thoracentesis
24. Ascites requiring paracentesis
25. Uncontrolled hypertension or uncontrolled diabetes
26. Any other clinically significant medical disease or condition that, in
the investigator’s opinion, may interfere with protocol adherence or
a subject’s ability to give informed consent
2. Glucocorticoid therapy within 14 days prior to randomization that
equals or exceeds a cumulative dose of 160 mg of dexamethasone
3. POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)
4. Plasma cell leukemia (> 2.0 × 109
/L circulating plasma cells by
standard differential)
5. Waldenström macroglobulinemia (WM)
6. Known amyloidosis
7. Focal radiation therapy within 7 days prior to randomization
8. Any immunotherapy within 21 days prior to randomization
9. Major surgery within 21 days prior to randomization
10. Active congestive heart failure (New York Heart Association
[NYHA] Class III to IV), symptomatic ischemia, conduction
abnormalities uncontrolled by conventional intervention, acute
diffuse infiltrative pulmonary disease, pericardial disease, or
myocardial infarction within 6 months prior to randomization.
11. Active infection within 14 days prior to randomization
12. Known human immunodeficiency virus (HIV) seropositive,
hepatitis C infection, and/or hepatitis B (subjects with hepatitis B
surface antigen [SAg] or core antibody receiving and responding to
antiviral therapy directed at hepatitis B are allowed)
13. Known cirrhosis
14. Second malignancy within the past 5 years except:
Adequately treated basal cell or squamous cell skin cancer,
Carcinoma in situ of the cervix, or
Prostate cancer < Gleason score 6 with undetectable prostatespecific antigen (PSA) over 12 months, or
Ductal breast carcinoma in situ with full surgical resection (i.e.,
negative margins), or
Treated medullary or papillary thyroid cancer, or
Similar condition with an expectation of >95 % 5-year disease
free survival
15. Myelodysplastic syndrome
16. Significant neuropathy (Grades ≥ 2) within 14 days prior to
randomization
17. Female subjects who are pregnant or lactating
18. Known history of allergy to Captisol (a cyclodextrin derivative
used to solubilize carfilzomib)
19. Hypersensitivity to boron, or mannitol (associated with bortezomib
administration)
20. Hypersensitivity to melphalan or to any of the excipients of
Alkeran
21. Contraindication to prednisone or dexamethasone
22. Contraindication to any of the required concomitant drugs or
supportive treatments, including hypersensitivity to antiviral drugs,
or intolerance to hydration due to preexisting pulmonary or cardiac
impairment
23. Pleural effusions requiring thoracentesis
24. Ascites requiring paracentesis
25. Uncontrolled hypertension or uncontrolled diabetes
26. Any other clinically significant medical disease or condition that, in
the investigator’s opinion, may interfere with protocol adherence or
a subject’s ability to give informed consent
The Estimated Number of Participants
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Taiwan
21 participants
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Global
882 participants
