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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002158

Enrollment

Registered

2009-07-06

Start date

2009-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Newly diagnosed multiple myeloma using IMWG criteria excluding stem cell transplantaion patient. Detection of M protein by serum or urine. Monoclonarity of plasma cell in BM or plasmacytoma. Organ disorder: renal failure (Cr>2mg/dl), anemia (Hb<10g/dl,or over 2g/dl decreased), bone lesion (lytic lesion or osteoporosis with compression fracture), others (hyperviscosity syndrome, amyloidosis, bacterial infection (over 2 times/ year) (2)Definition of exclusion of stem cell transplantation. Imposssible for high dose chemotherapy or disagreement of SCT. (3) Osteolytic bone disease diagnosed by X-P, CT or MRI. (4) Over 1 year survival patient (5) No severe organ damage AST (under 2 times of limit level) ALT (under 2 times of limit level) T-Bil (under 2 times of limit level) Ccr 30 ml/min (6) Informed consent by document

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Analysis of skeletal-related events on 48 weeks after treatment.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactHiroshi Handa

Gunma University Division of health

hhanda@health.gunma-u.ac.jp027-220-8973

Outcome results