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

UMIN ID: UMIN000002158

Registered date:06/07/2009

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 2009/07/01
• Target sample size: 5
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Analysis of skeletal-related events on 48 weeks after treatment.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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)

Related Information

• Primary Sponsor: Division of clinial oncology and hematology, Jikei University School of Medicine
• Source(s) of Monetary Support: Gumma University, and Jikei University