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

NCT03992170 | Unknown Phase 2 DMC

• 1 other identifier: DART4MM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma Multiple

Keywords

Myeloma Multiple; Daratumumab

Outcome Measures

Primary Outcomes (1)

• Overall Responde Rate (ORR)

  The fraction of patients who experience a Minimal Residual Disease (MRD) negativity per IMWG 2016 criteria

  every 6 months

Secondary Outcomes (3)

• Progression free survival (PFS)

  every 6 months

• Complete Remission Rate (CR)

  every 6 months

• Duration of Response (DoR)

  every 6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Daratumumab DRUG

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.

Also known as: Darzalex

Single Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead
• Janssen-Cilag S.p.A.: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

RECRUITING

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alessandro Gozzetti, Medicine

  Azienda Ospedaliera Universitaria Senese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiana Cafarelli, Letters

CONTACT

0039 0577586718; cristianacafarelli21@gmail.com

Francesca Di Martino, Pharmacy

CONTACT

0039 0577586798; francesca.dimartino29@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 20, 2019
• Study Start: December 31, 2018
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)