To hear about similar clinical trials, please enter your email below
Trial Title:
Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD
NCT ID:
NCT06418477
Condition:
Monoclonal Gammopathy of Renal Significance
Conditions: Official terms:
Immunoglobulin Light-chain Amyloidosis
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Conditions: Keywords:
Daratumumab
Bortezomib
Monoclonal Immunoglobulin Deposition Disease
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
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.
Arm group label:
Dara-CyBorD
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Recruiting
Contact:
Last name:
Junling Zhuang
Email:
zhuangjunling@hotmail.com
Contact backup:
Last name:
Junling Zhuang, MD
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Liu
Phone:
+8613716926210
Email:
pkuphliuyang@bjmu.edu.cn
Contact backup:
Last name:
Jin Lu, MD
Facility:
Name:
The First Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Li
Email:
13719209240@163.com
Contact backup:
Last name:
Juan Li, MD
Start date:
June 15, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06418477
