## Protocol Section
### Identification Module
**NCT ID:** NCT06418477

**Brief Title:** Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients With MIDD

**Official Title:** Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients With Monoclonal Immunoglobulin Deposition Disease

#### Organization Study ID Info
**ID:** 2024PHB134-001
#### Organization
**Class:** OTHER
**Full Name:** Peking University People's Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-28

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking University People's Hospital

#### Responsible Party

**Investigator Affiliation:** Peking University People's Hospital

**Investigator Full Name:** Jin Lu, MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.

**Detailed Description:** The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.

### Conditions Module

**Conditions:**

- Monoclonal Gammopathy of Renal Significance

**Keywords:**

- Daratumumab

- Bortezomib

- Monoclonal Immunoglobulin Deposition Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Daratumumab:

Cyclophosphamide Bortezomib Dexamethasone

**Intervention Names:**

- Drug: Dara-CyBorD

**Label:** Dara-CyBorD

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dara-CyBorD

**Description:** Patient will receive Dara-CyBorD (Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone) for at least 6 cycles, and then Daratumumab maintainance.

Drug: Daratumumab: 16mg/kg IV dose OR 1800 mg subcutaneously Drug: Cyclophosphamide: 300 mg/m\^2 as an oral or IV dose Drug: Bortezomib: 1.3 mg/m\^2 as an subcutaneous (SC) injection. Drug: Dexamethasone: 20-40mg Patients will receive the above drugs (Dara-CyBorD) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 1 years.

Note: If patients achieve less than hematologic VGPR by cycle 3 or less than PR by cycle 2, treatment plan will be allowed to discontinued, according to treatment principle in systemic light chain amyloidosis.

**Name:** Dara-CyBorD

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Hematologic complete response requires absence of monoclonal protein by immunofixation electrophoreses of both serum and urine as well as a normal FLC ratio (FLCr). CR is considered when FLCr was altered in favour of the non-amyloidogenic, uninvolved FLC (uFLC), even though the ratio may not have been normalised.

**Measure:** Rate of Hematologic Complete Response at the completion of 6 cycles

**Time Frame:** 6 months

#### Secondary Outcomes

**Measure:** Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels

**Time Frame:** 6 months

**Measure:** Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels

**Time Frame:** 6 months

**Description:** Renal response at 6 months

**Measure:** Renal response at 6 months

**Time Frame:** 6 months

**Description:** Cardiac response (for patients with cardiac involvement) at 6 months

**Measure:** Cardiac response at 6 months

**Time Frame:** 6 months

**Description:** Minimal residual disease status at 6 months

**Measure:** MRD status at 6 months

**Time Frame:** 6 months

**Description:** Renal Survival in 2 years

**Measure:** Renal Survival in 2 years

**Time Frame:** 2 years

**Description:** Overall Survival in 2 years

**Measure:** Overall Survival in 2 years

**Time Frame:** 2 years

**Description:** Treatment-related adverse events up to 2 years

**Measure:** TRAEs

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
2. ECOG 0,1,2
3. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L.
4. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
5. Informed consent explained to, understood by and signed by the patient.

Exclusion Criteria:

1. Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
4. Severe or persistent infection that cannot be effectively controlled;
5. Presence of severe autoimmune diseases or immunodeficiency disease;
6. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
7. Patients with HIV infection or syphilis infection;
8. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jin1lu@sina.com

**Name:** Jin Lu

**Phone:** 86-13311491805

**Role:** CONTACT

**Contact 2:**

**Email:** pkuphliuyang@bjmu.edu.cn

**Name:** Yang Liu

**Phone:** 86-13716926210

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** zhuangjunling@hotmail.com

- **Name:** Junling Zhuang

- **Role:** CONTACT

***Contact 2:***

- **Name:** Junling Zhuang, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Peking Union Medical College Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100005

**Location 2:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** pkuphliuyang@bjmu.edu.cn

- **Name:** Yang Liu

- **Phone:** +8613716926210

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jin Lu, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Peking University People's Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100044

**Location 3:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

- **Email:** 13719209240@163.com

- **Name:** Juan Li

- **Role:** CONTACT

***Contact 2:***

- **Name:** Juan Li, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** The First Affiliated Hospital, Sun Yat-sen University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510062

#### Overall Officials

**Official 1:**

**Affiliation:** Peking University People's Hospital

**Name:** Jin Lu

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000006942

- Term: Hypergammaglobulinemia

- ID: D000054219

- Term: Neoplasms, Plasma Cell

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000686

- Term: Amyloidosis

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000008232

- Term: Lymphoproliferative Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11962

- Name: Monoclonal Gammopathy of Undetermined Significance

- Relevance: HIGH

- As Found: Monoclonal Gammopathy

- ID: M4021

- Name: Amyloidosis

- Relevance: LOW

- As Found: Unknown

- ID: M1483

- Name: Immunoglobulin Light-chain Amyloidosis

- Relevance: HIGH

- As Found: Monoclonal Immunoglobulin Deposition Disease

- ID: M13178

- Name: Paraproteinemias

- Relevance: HIGH

- As Found: Monoclonal Gammopathy

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- 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: M9993

- Name: Hypergammaglobulinemia

- Relevance: LOW

- As Found: Unknown

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T3867

- Name: Monoclonal Gammopathy of Undetermined Significance

- Relevance: HIGH

- As Found: Monoclonal Gammopathy

- ID: T254

- Name: AL Amyloidosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000075363

- Term: Immunoglobulin Light-chain Amyloidosis

- ID: D000010265

- Term: Paraproteinemias

- ID: D000008998

- Term: Monoclonal Gammopathy of Undetermined Significance

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M7102

- Name: Dexamethasone

- Relevance: LOW

- As Found: Unknown

- ID: M6727

- Name: Cyclophosphamide

- Relevance: LOW

- As Found: Unknown

- ID: M376

- Name: Bortezomib

- Relevance: LOW

- As Found: Unknown

- ID: M272211

- Name: Daratumumab

- Relevance: LOW

- As Found: Unknown

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M12147

- Name: Myeloma Proteins

- Relevance: LOW

- As Found: Unknown

- ID: M13179

- Name: Paraproteins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
