NCT02095379

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

February 13, 2014

Last Update Submit

March 20, 2014

Conditions

Multiple Myeloma

Keywords

oligosecretary multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Number of patients with oligosecretary myeloma among multiple myeloma patients

    up to 1 year

Study Arms (1)

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

Interventions

oligosecretaryOTHER

not abvailable

oligosecretary

Eligibility Criteria

Age17 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • patients without available clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Kihyun Kim

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2014

First Posted

March 24, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

KR(1)