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New treatment option for Monoclonal Gammopathy of Renal Significance
Official title Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD
ClinicalTrials.gov ID: NCT06418477
What this study is testing
What is Dara-CyBorD?
Dara-CyBorD is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for monoclonal gammopathy of renal significance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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+]);
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.