Monoclonal Gammopathy of Renal SignificancePhase 2NCT06418477
Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD
A Phase 2 study testing Dara-CyBorD in people with Monoclonal Gammopathy of Renal Significance, run by Peking University People's Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Renal Significance
- What is being tested?
- Dara-CyBorD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 15 Jun 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
- ECOG 0,1,2
- Neu≥ 1.0*10^9/L, HGB ≥70g/L, PLT ≥ 50*10^9/L.
- Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
- Informed consent explained to, understood by and signed by the patient.
Who cannot join
- Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
- Patients with HIV infection or syphilis infection;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Junling Zhuang, zhuangjunling@hotmail.com
Junling Zhuang, MD
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yang Liu, +8613716926210, pkuphliuyang@bjmu.edu.cn
Jin Lu, MD
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510062
Juan Li, 13719209240@163.com
Juan Li, MD
About this study
Official title: Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease
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.
Read the 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.
- Being tested
- Dara-CyBorD
- Keywords
- Daratumumab, Bortezomib, Monoclonal Immunoglobulin Deposition Disease
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dara-CyBorDDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dara-CyBorD | Experimental | Daratumumab:
Cyclophosphamide Bortezomib Dexamethasone Receives: Drug: Dara-CyBorD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hematologic Complete Response at the completion of 6 cycles
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.
Measured: 6 months
Secondary outcomes (8)
Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels
Measured: 6 months
Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels
Measured: 6 months
Renal response at 6 months
Renal response at 6 months
Measured: 6 months
Cardiac response at 6 months
Cardiac response (for patients with cardiac involvement) at 6 months
Measured: 6 months
MRD status at 6 months
Minimal residual disease status at 6 months
Measured: 6 months
Renal Survival in 2 years
Renal Survival in 2 years
Measured: 2 years
Overall Survival in 2 years
Overall Survival in 2 years
Measured: 2 years
TRAEs
Treatment-related adverse events up to 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start15 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Renal SignificanceStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
- Investigators
- Jin Lu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418477
- Sponsor's protocol ID
- 2024PHB134-001
- Status last verified
- Sep 2024
- First submitted
- 13 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease
- ClinicalTrials.gov ID
- NCT06418477
- Acronym / sponsor ID
- 2024PHB134-001
- Keywords
- Daratumumab, Bortezomib, Monoclonal Immunoglobulin Deposition Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dara-CyBorD | Experimental | Drug: Dara-CyBorDDaratumumab: Cyclophosphamide Bortezomib Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
- ECOG 0,1,2
- Neu≥ 1.0*10^9/L, HGB ≥70g/L, PLT ≥ 50*10^9/L.
- Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
- Informed consent explained to, understood by and signed by the patient.
Key exclusion criteria (8 listed)
- Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dara-CyBorDPatient 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. | Drug | Dara-CyBorD |
Primary outcome
Rate of Hematologic Complete Response at the completion of 6 cycles
Time frame: 6 months
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.
8 secondary outcomes
Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels
Time frame: 6 months
Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels
Time frame: 6 months
Renal response at 6 months
Time frame: 6 months
Cardiac response at 6 months
Time frame: 6 months
MRD status at 6 months
Time frame: 6 months
Renal Survival in 2 years
Time frame: 2 years
Overall Survival in 2 years
Time frame: 2 years
TRAEs
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jin Lu principal investigator
Peking University People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dara-CyBorD in people with Monoclonal Gammopathy of Renal Significance, run by Peking University People's Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Lu (86-13311491805, jin1lu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Hematologic Complete Response at the completion of 6 cycles (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.