Treatment for newly diagnosed monoclonal immunoglobulin deposition disease

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

This study is testing a new combination treatment for people who have just been diagnosed with monoclonal immunoglobulin deposition disease to see if it helps improve their blood health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: daratumumab, cyclophosphamide
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06418477 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 2 study investigates the efficacy of a treatment regimen consisting of daratumumab, bortezomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will be enrolled to receive this combination therapy, with the primary endpoint being the overall complete hematologic response rate assessed at 6 months. The study aims to provide insights into the effectiveness of this treatment approach for this specific condition.

Who should consider this trial

Good fit: Ideal candidates for this study are patients newly diagnosed with monoclonal immunoglobulin deposition disease who have not received prior anti-plasma cell treatment.

Not a fit: Patients with active multiple myeloma, advanced malignant tumors, or severe autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hematologic responses in patients with monoclonal immunoglobulin deposition disease.

How similar studies have performed: While this approach is novel for monoclonal immunoglobulin deposition disease, similar therapies have shown promise in treating related conditions.

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jin Lu — Peking University People's Hospital
• Study coordinator: Jin Lu

Conditions Monoclonal Gammopathy of Renal Significance; Daratumumab; Bortezomib; Monoclonal Immunoglobulin Deposition Disease