RECRUITINGPhase 2INTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. willing to sign a consent form explained to, understood by and signed by the patient. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s or weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Dara-CyBorD

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.

Locations (3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China