ClinicalTrials.gov record NCT06418477

Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Oct 1, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label Phase 2 study gives a four-drug combination (daratumumab, bortezomib, cyclophosphamide, dexamethasone) to people with newly diagnosed monoclonal immunoglobulin deposition disease. About 25 participants will receive at least six 28-day cycles, with daratumumab maintenance thereafter. The main measure is hematologic complete response at 6 months; other outcomes include kidney and heart responses, minimal residual disease, survival, and treatment-related adverse events up to 2 years.

What it is studying. The study is measuring the hematologic complete response rate at 6 months after treatment with daratumumab plus bortezomib, cyclophosphamide, and dexamethasone. It also assesses combined response rates, renal and cardiac responses, minimal residual disease, survival at 2 years, and treatment-related adverse events.

What the researchers hope to learn. Primary scientific goal: measure hematologic complete response (CHR) rate at 6 months. Secondary goals: measure CR+VGPR rates, overall response rate, renal and cardiac responses at 6 months, minimal residual disease at 6 months, renal and overall survival at 2 years, and treatment-related adverse events up to 2 years.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Dara-CyBorD

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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.

Exclusion criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive the study regimen Dara‑CyBorD (daratumumab plus bortezomib, cyclophosphamide, and dexamethasone) on a 28‑day cycle for at least six cycles, with daratumumab continued as maintenance (weekly then every 2 weeks then every 4 weeks) for up to one year or until progression/subsequent therapy. Drugs may be given by intravenous or subcutaneous routes and cyclophosphamide orally or IV as described in the protocol. Treatment may be discontinued according to response rules (for example if response is below set thresholds by cycle 2–3). Regular clinic visits, safety monitoring and follow‑up (including adverse‑event monitoring and assessments relevant to blood, kidney and heart function) will occur, with some safety and survival follow‑up captured for up to two years.

How the study is structured. Phase 2, open-label, single-group interventional study. All participants receive the Dara-CyBorD regimen for up to six 28-day cycles; daratumumab is given weekly for the first 8 weeks, then every 2 weeks for cycles 3–6, then every 4 weeks up to one year or until progression or next therapy. Primary outcome is assessed at 6 months; other outcomes and safety are followed up to 2 years. Approximately 25 subjects; there is no placebo or comparison arm.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Monoclonal Gammopathy of Renal Significance. Does it apply to my diagnosis?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jun 15, 2024
Primary completion
Dec 31, 2025 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
Oct 1, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking University People's Hospital
Principal investigator
Jin Lu, MD, Principal Investigator
Peking University People's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

  • Peking Union Medical College HospitalRecruiting

    Beijing, Beijing Municipality, 100005 · China

  • Peking University People's HospitalRecruiting

    Beijing, Beijing Municipality, 100044 · China

  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting

    Guangzhou, Guangdong, 510062 · China

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Prior therapy
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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