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Oligosecretary Myeloma: Prevalence and Its Clinical Significance

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ClinicalTrials.gov Identifier: NCT02095379
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Kihyun Kim, Samsung Medical Center

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

Condition or disease Intervention/treatment
Multiple Myeloma Other: oligosecretary

Detailed 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.


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Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Oligosecretary Myeloma: Prevalence and Its Clinical Significance
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
oligosecretary
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)
Other: oligosecretary
not abvailable




Primary Outcome Measures :
  1. Number of patients with oligosecretary myeloma among multiple myeloma patients [ Time Frame: up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095379


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Kihyun Kim Samsung Medical Center

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Responsible Party: Kihyun Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02095379     History of Changes
Other Study ID Numbers: 2014-02-055
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014
Keywords provided by Kihyun Kim, Samsung Medical Center:
oligosecretary multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases