UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034815 |
|---|---|
| Receipt number | R000039704 |
| Scientific Title | Response-oriented sequential therapy with four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma |
| Date of disclosure of the study information | 2018/11/08 |
| Last modified on | 2025/11/04 17:49:41 |
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Basic information
Public title
Response-oriented sequential therapy with four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma
Acronym
Response-oriented MPB/Rd sequential therapy for NDMM
Scientific Title
Response-oriented sequential therapy with four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma
Scientific Title:Acronym
Response-oriented MPB/Rd sequential therapy for NDMM
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a treatment strategy which makes the most of bortezomib/melphalan/prednisolone therapy (MPB) and lenalidomide/dexamethasone therapy (Ld), we conducted the multi-institutional phase 2 study of response-oriented first-line 4 cycles of MPB followed by continuous Ld therapy to investigate its efficacy and feasibility in Japanese transplant-ineligible NDMM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We treat transplant ineligible newly diagnosed myeloma patients aged between 66-80 with up to 4 cycles of MPB. Treatment will be switched to Ld in case patients who did not achieve complete response by up to 4 cycles of MPB or who are intolerable to MPB.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 66 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Transplant-ineligible symptomatic untreated myeloma
Key exclusion criteria
plasma cell leukemia, cardiac amyloidosis, POEMS syndrome, grade 2-4 neuropathy, other malignancy within past 3 years, and other serious complications
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | JUNYA |
| Middle name | |
| Last name | KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematology and Oncology
Zip code
602-8566
Address
Kyoto
TEL
0752515740
junkuro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | JUNYA |
| Middle name | |
| Last name | KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematology and Oncology
Zip code
602-8566
Address
Kyoto
TEL
0752515740
Homepage URL
junkuro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
Tel
075-251-5373
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00277-019-03859-9
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00277-019-03859-9
Number of participants that the trial has enrolled
36
Results
In this study, 36 NDMM patients (median age 74) received four 35-day cycles of VMP: melphalan 6 mg/m2 and prednisolone 60 mg/m2 on days 1-4, and bortezomib 1.3 mg/m2 on days 1, 8, 15, and 22. Then 33 patients switched to 28-day Rd until progression or unacceptable AEs, while one CR patient remained on VMP. ORR after VMP and Rd was 66.7% and 86.1%, with CR rates of 5.6% and 36.1%. At a median follow-up of 34.3 months, 3-year PFS and OS were 43.2% and 81.3%.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 74 years (range, 67-80), 19 (52.8%) were male, 15 (41.7%) were classified as stage III in the International Staging System (ISS). Four patients (11.1%) had an extramedullary lesion, and 6 (16.7%) harbored high risk cytogenetics, including t(4;14), t(14;16) and/or del(17p). BTZ was administered subcutaneously in 33 patients (91.7%) and by intravenous injection in 3 patients (8.3%).
Participant flow
Patients were enrolled from August 2012 to December 2016 at seven centers in the Kyoto Clinical Hematology Study Group (KOTOSG).
Adverse events
Grade 3 to 4 hematological AEs with VMP were neutropenia in 39% of patients, anemia in 36%, and thrombocytopenia in 11%; and those with Rd were neutropenia in 24%, anemia in 15%, and thrombocytopenia in 3%. Grade 3 to 4 non-hematological AEs during VMP included respiratory infection (n=2), and PN, diarrhea, nausea, fatigue, anorexia, acute pancreatitis, and otitis media (each n=1); and those with Rd included skin rash (n=3), neurologic disorders (n=3), such as consciousness disorder, tremor and dementia (each n=1), and deep vein thrombosis, liver dysfunction, sepsis, and depression (each n=1). Treatment was discontinued due to AEs in 5/36 patients (13.9%) during VMP, and 10/33 during Rd (30.3%). Treatment discontinuation in the 5 patients during VMP was due to diarrhea, BTZ-induced PN, acute pancreatitis, severe anorexia, and severe fatigue (each n=1), all of which could not be controlled by dose reduction of BTZ and supportive treatment. These AEs were all considered to be associated with BTZ. Treatment discontinuation during Rd was associated with neurologic symptoms (n=3), skin rash (n=3), and deep vein thrombosis, liver dysfunction, sepsis and depression (each n=1), some of which were considered to be associated with LEN. No grade 5 AEs occurred throughout the study.
Outcome measures
ORR, i.e., the rate of >= partial response (PR), was chosen as the primary endpoint. Secondary endpoints included rates of >= CR and >= very good PR (VGPR), OS, PFS, and safety. OS and PFS were estimated by the Kaplan-Meier method. The response to treatment was defined using the International Uniform Response Criteria. After treatment, AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), ver. 3.0.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039704
