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A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow (DART4MM)

Studio Clinico

Patologia: Mieloma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Schema di trattamento: 

Patients will receive Daratumumab (16 mg/Kg day) every week for 8 weeks intravenous (8 infusions) and then every 2 weeks for 16 weeks intravenous (8 more infusions).
If MRD positive by NGF, the patients will receive Daratumumab every 4 weeks for 80 weeks intravenous; if MRD negative by NGF, the patients can stop the treatment.

Trattamento sperimentale: 

Daratumumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Overall Responde Rate (ORR) [ Time Frame: every 6 months ]
The fraction of patients who experience a Minimal Residual Disease (MRD) negativity per IMWG 2016 criteria

Obiettivi secondari dello studio: 

- Progression free survival (PFS) [ Time Frame: every 6 months ]
PFS determined using the Kaplan-Meier method, considering those who progress or die without progression as failures, and censoring those who do not

- Complete Remission Rate (CR) [ Time Frame: every 6 months ]
The fraction of patient who experience a sCR using the study treatment

- Duration of Response (DoR) [ Time Frame: every 6 months ]
The fraction of patients who continues to respond to treatment without Myeloma progression

Centri partecipanti

Centro Italia

Ospedale Mazzoni
Via degli Iris - 63100 Ascoli - AP
Ematologia

 

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Ematologia

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
Ematologia

 

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Ematologia

Riferimento: Prof. Alessandro Gozzetti
Telefono: 0577586718
Email: gozzetti@unisi.it

 

AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR
Ematologia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT03992170

Data di inserimento: 03.02.2020

Promotore

Azienda Ospedaliera Universitaria Senese

CRO

/

Principal Investigator ITALIA

AOU Senese

Riferimento: Prof. Alessandro Gozzetti

Telefono: 0577586718

Email: gozzetti@unisi.it

Localita: Siena

 

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