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Clinical study of MP plus zoledronic acid therapy in newly diagnosed multiple myeloma excluding stem cell transplantation patients

Not Applicable
Conditions
Multiple Myeloma
Registration Number
JPRN-UMIN000002158
Lead Sponsor
Division of clinial oncology and hematology, Jikei University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
5
Inclusion Criteria

Not provided

Exclusion Criteria

(1)Treatment history with bisphosphonate within 3 years. (2) Double cancer (or more) or cancer past history. (3)Uncontrollable any complication or infection. (4) Class III or IV heart disease by NYHA classification. (5) Under pregnancy, breast-feeding. (6) Dental infection (within 4 weeks after dental treatment). (7)Viral hepatitis (HBs antigen or HCV antibody positive) (8) Patient applied other clinical study. (9)Others (inappropriate case)

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Analysis of skeletal-related events on 48 weeks after treatment.
Secondary Outcome Measures
NameTimeMethod
Analysis of skeletal-related events on 104 weeks after treatment. Response rate of MP plus zoledronic acid on 48 weeks after treatment. Analysis of bone metabolism marker. Analysis of bone density (L2-L4) using DXA method. Frequency of therapy-related toxicity.
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