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NCT02095379 Clinical Trial

Oligosecretary Myeloma: Prevalence and Its Clinical Significance

Multiple Myeloma Clinical Trial

Official title:
Oligosecretary Myeloma: Prevalence and Its Clinical Significance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02095379
Other study ID # 2014-02-055
Secondary ID
Status Completed
Phase N/A
First received February 13, 2014
Last updated March 20, 2014
Start date October 2013
Est. completion date February 2014

Study information
Verified date March 2014
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

In this study, the investigators aim to investigate the prevalence and clinical course of oligosecretary myeloma.

Description:

Oligosecretary myeloma is a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day). Patients with oligosecretary myeloma do not have established methods for disease monitoring and clinical informations regarding oligosecretary myeloma are still largely unknown.

In this study, we aimed to investigate the prevalence and clinical course of oligosecretary myeloma.

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 90 Years
Eligibility Inclusion Criteria:

- a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein = 1g/dL, a urine M protein = 200mg/day)

- available clinical data

Exclusion Criteria:

- patients without available clinical data

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• oligosecretary
not abvailable

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with oligosecretary myeloma among multiple myeloma patients up to 1 year No
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