Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this study is to evaluate Daratumumab effect on MRD-positive patients with Multiple Myeloma (MM) who achieved >VGPR after any therapy (ASCT, VMP, Rev-Dex). Daratumumab 16 mg/kg administered at weekly intervals for 8 weeks, then every 2 weeks for an additional 16 weeks, will be given to 50 MM patients who achieved a >VGPR defined by monoclonal component disappearance in serum or urine, immunofixation positive/negative and MRD-positivity (by NGF). Free light chain (FLC) and CT/PET will be evaluated at time 0. NGF will be done on marrow aspirate at time 0, at 2 months and every 6 months for 2 years. If patients will be still MRD positive after 6 months of therapy , treatment will be continued up to 2 years. If MRD negative by NGF, the patients can stop the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Senese
• Collaborator: Janssen-Cilag S.p.A.
• Treatments: Antibodies, Monoclonal; Daratumumab

Criteria

Inclusion Criteria:

• Able to adhere to the study visit schedule and other protocol requirements

• >VGPR/MRD-positive by NGF measured by 2-tubes optimized 8-color antibody panel, (OneFlow PCST e PCD BD Biosciences)

• Patients should be at enrollment at least 12 weeks from any therapy for myeloma after diagnosis or at any subsequent relapse

• Eastern Cooperative Oncology Group performance status score of 0, 1, or 2

• Laboratory values and electrocardiogram within protocol-defined parameters at screening

• All previous MM therapy, including radiation, cytostatic therapy and surgery, must have been terminated at least 4 weeks prior to treatment in this study, without corticosteroid therapy.

• Laboratory test results within these ranges:

• Absolute neutrophil count 1.0 x 109/L

• Platelet count 75 x 109/L

• Creatinine clearance > 30 ml/h)

• Total bilirubin 1.5 mg/Dl

• Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) 2 x ULN

• Disease free of prior malignancies for 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

• Fertile patients must use effective contraception during and for 6 months after study treatment

• Patients must sign on an Informed Consent Form No study treatment or any other procedure within the framework of the trial (except for screening) will be performed in any patient prior to receipt of written informed consent.

Exclusion Criteria:

• Received Daratumumab or other anti-CD38 therapies previously

• Nonsecretory multiple myeloma

• Previously received an allogenic stem cell transplant or has received an autologous stem cell transplantation within 12 weeks

• Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years

• Absence of the Informed Consent Form signed by the patient

• Pregnant or breast feeding females

• Use of any other experimental drug or therapy within 28 days of baseline.

• Known hypersensitivity to the study drugs

• Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C.

• Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis