UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001435 |
|---|---|
| Receipt number | R000001699 |
| Scientific Title | Combination therapy of melphalan plus prednisolone and zoledronic acid for untreated multiple myeloma patients ineligible for autologous stem cell transplantation |
| Date of disclosure of the study information | 2008/10/17 |
| Last modified on | 2012/05/23 08:03:32 |
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Basic information
Public title
Combination therapy of melphalan plus prednisolone and zoledronic acid for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Acronym
MP + zoledronic acid therapy for untreated multiple myeloma
Scientific Title
Combination therapy of melphalan plus prednisolone and zoledronic acid for untreated multiple myeloma patients ineligible for autologous stem cell transplantation
Scientific Title:Acronym
MP + zoledronic acid therapy for untreated multiple myeloma
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of combination therapy of melphalan plus prednisolone and zoledronic acid for untreated multiple myeloma patients ineligible for autologous stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients experiencing skeletal-related events (SRE, defined as a pathologic fracture, radiation therapy to bone, surgery to bone, spinal cord compression, hypercalcemia) for 48 weeks.
Key secondary outcomes
1) The proportion of patients experiencing SRE for 104 weeks
2) Response rate (CR+PR) of the combination of MP and zoledronic acid at 48 weeks
3) The changes in serum markers of bone turnover (serum NTX and BSAP)
4) The changes in lumber spine BMD (L2-L4)
5) Frequency of adverse events
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
Melphalan (6mg/m2) and prednisone (40mg/m2) are given orally for 4 days. MP therapy will be given continuously every 4 weeks unless serious adverse events occur, or the patients meet the criteria as follows;
1) If CR, PR or MR and plateau-phase are achieved, and plateau phase continue for 3 months, MP therapy will be stopped. After discontinuation of MP therapy, MP therapy will be given again, if M-protein increase.
2) The efficacy at 12 week is NC or PD, MP therapy will be discontinued and changed to appropriate chemotherapy.
Zoledronic acid is administered intravenously over 15 minutes at the dose of 4mg or an adjusted dose based on renal function every 4 weeks for 2 years.( 26 times infusion for 100 weeks )
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with a confirmed diagnosis of multiple myeloma (symptomatic) according to the IMWG criteria defined as follows:
A. M-protein in serum and/or urine
B. Bone marrow clonal plasma cells or plasmacytoma
C. Related organ or tissue impairment (end organ damage, including bone lesions)
1)Renal insufficiency
2)Anaemia
3)Lytic bone lesions
4)Others: hyperviscosity, amyloidosis, recurrent infections
2. Patients ineligible for autologous stem cell transplantation are defined as:
1) Those impossible to receive high dose chemotherapy
2) Those who do not request transplants
3. Those with at least one osteolytic bone lesion (confirmed by diagnostic imaging with X-ray or CT or MRI)
4. Those with a life expectancy of at least 1 year
5. Those with ECOG performance status: 0-2 (Patients with PS 3 restricted by bone lesions are allowed to participate )
6. Those with adequate organ function
1)AST, ALT, T-Bil<X2 ULM
2)Ccr>=30 mL/min
7. Those who have given written informed consent.
Key exclusion criteria
1)Patients with prior treatment with intravenous bisphosphonate
2)Those with previous or concomitant malignancy
3)Those with uncontrolled complications or infectious diseases
4)Those with severe cardiac dysfunction( NYHA classification: 3-4)
5)Those who are pregnant or breast-feeding or potential
6)Those who have current active dental problems including infection of the teeth or jawbone. Recent or planned dental or jaw surgery(e.g. extraction, implants)
7)Those known to have active Hepatitis B or C Viral Infection ( HBs(+) or HCV(+) )
8)Patients participating other clinical studies
9)Those who are inadequate to be enrolled in the protocol study by the investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Murakami |
Organization
Gunma University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Handa |
Organization
Gunma University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8994
Homepage URL
hhanda@health.gunma-u.ac.jp
Sponsor or person
Institute
Myeloma Bone Disease Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 17 | Day |
Last modified on
| 2012 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001699
