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Trial record 1 of 123 for:    daratumumab multiple myeloma
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Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive (DART4MM)

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ClinicalTrials.gov Identifier: NCT03992170
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Janssen-Cilag S.p.A.
Information provided by (Responsible Party):
Alessandro Gozzetti, Azienda Ospedaliera Universitaria Senese

Brief 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.

Condition or disease Intervention/treatment Phase
Myeloma Multiple Drug: Daratumumab Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Efficacy of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive by Next Generation Flow
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Daratumumab

Arm Intervention/treatment
Experimental: Single Arm

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.

Drug: Daratumumab
Daratumumab is a human monoclonal antibody (mAb) IgG1 that binds to the highly expressed CD38 protein on the surface of multiple myeloma cells and, at various levels, also in other types of cells and tissues. The CD38 protein has multiple functions, such as receptor-mediated adhesion, signal transduction activity and enzymatic activity.
Other Name: Darzalex




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992170


Contacts
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Contact: Cristiana Cafarelli, Letters 0039 0577586718 cristianacafarelli21@gmail.com
Contact: Francesca Di Martino, Pharmacy 0039 0577586798 francesca.dimartino29@gmail.com

Locations
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Italy
Azienda Ospedaliera Universitaria Senese Recruiting
Siena, Italy, 53100
Contact: Cristiana Cafarelli, Letters    0039 0577586718    cristianacafarelli21@gmail.com   
Contact: Francesca Di Martino, Pharmacy    0039 0577586798    francesca.dimartino29@gmail.com   
Principal Investigator: Alessandro Gozzetti, Medicine         
Sub-Investigator: Francesca Bacchiarri, Medicine         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
Janssen-Cilag S.p.A.
Investigators
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Principal Investigator: Alessandro Gozzetti, Medicine Azienda Ospedaliera Universitaria Senese
  Study Documents (Full-Text)

Documents provided by Alessandro Gozzetti, Azienda Ospedaliera Universitaria Senese:

Additional Information:
Publications:

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Responsible Party: Alessandro Gozzetti, Professor, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT03992170     History of Changes
Other Study ID Numbers: DART4MM
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandro Gozzetti, Azienda Ospedaliera Universitaria Senese:
Myeloma Multiple
Daratumumab
Additional relevant MeSH terms:
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Multiple Myeloma
Daratumumab
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs