## Protocol Section
### Identification Module
**NCT ID:** NCT02095379

**Brief Title:** Oligosecretary Myeloma: Prevalence and Its Clinical Significance

**Official Title:** Oligosecretary Myeloma: Prevalence and Its Clinical Significance

#### Organization Study ID Info
**ID:** 2014-02-055
#### Organization
**Class:** OTHER
**Full Name:** Samsung Medical Center
### Status Module
#### Completion Date
**Date:** 2014-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-03-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-03-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-10

**Status Verified Date:** 2014-03

#### Study First Post Date
**Date:** 2014-03-24
**Type:** ESTIMATED
**Study First Submit Date:** 2014-02-13
**Study First Submit QC Date:** 2014-03-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Samsung Medical Center

#### Responsible Party

**Investigator Affiliation:** Samsung Medical Center

**Investigator Full Name:** Kihyun Kim

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

**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.

### Conditions Module

**Conditions:**

- Multiple Myeloma

**Keywords:**

- oligosecretary multiple myeloma

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 390

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

- Other: oligosecretary

**Label:** oligosecretary

### Interventions

#### Intervention 1

**Arm Group Labels:**

- oligosecretary

**Description:** not abvailable

**Name:** oligosecretary

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of patients with oligosecretary myeloma among multiple myeloma patients

**Time Frame:** up to 1 year

### Eligibility Module

**Eligibility 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

**Maximum Age:** 90 Years

**Minimum Age:** 17 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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)

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Samsung Medical Center

#### Overall Officials

**Official 1:**

**Affiliation:** Samsung Medical Center

**Name:** Kihyun Kim

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010265

- Term: Paraproteinemias

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12058

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: HIGH

- As Found: Myeloma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13178

- Name: Paraproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3947

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

### Condition Browse Module - Meshes

- ID: D000009101

- Term: Multiple Myeloma

- ID: D000054219

- Term: Neoplasms, Plasma Cell

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12147

- Name: Myeloma Proteins

- Relevance: LOW

- As Found: Unknown

- ID: M13179

- Name: Paraproteins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
