Active — Not RecruitingPhase 2

Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease

Greece, Italy, Turkey (Türkiye)41 participantsStarted 2019-10-31

Plain-language summary

This trial will try to establish the feasibility and efficacy of the combination of DaraVCD in Multiple Myeloma (MM) patients presenting with extramedullary disease (EMD). The study will be conducted as a Phase II trial. Forty patients will be included in the study cohort. All patients will be followed closely for toxicities and response assessment. After completion of treatment, patients will be followed every 6 months for survival until 5 years after enrolment

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
✓. Newly diagnosed or relapsed (patients should have received a maximum of one line of prior therapy) patients presenting with extramedullary disease (EMD) of the skin, liver, lungs, central nervous system, lymph nodes or other tissues, but not solely paraskeletal plasmacytoma (expanding soft tissue masses)\* detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy\*\*. Documentation of plasma cell infiltration is highly recommended unless it requires invasive surgical intervention such as intracerebral infiltration of plasmacytomas.
✓. Patients with one prior line of therapy must have:
✓. Age ≥ 18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Note: for patients with central nervous system (CNS) involvement, an ECOG performance status \>2 is also acceptable
✓. Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
✓. Patient must have measurable disease of MM as defined by the below criteria:

What they're measuring

CR or better

Timeframe: 5 years

Trial details

NCT IDNCT04166565

SponsorStichting European Myeloma Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Multiple Myeloma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
✓. Newly diagnosed or relapsed (patients should have received a maximum of one line of prior therapy) patients presenting with extramedullary disease (EMD) of the skin, liver, lungs, central nervous system, lymph nodes or other tissues, but not solely paraskeletal plasmacytoma (expanding soft tissue masses)\* detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy\*\*. Documentation of plasma cell infiltration is highly recommended unless it requires invasive surgical intervention such as intracerebral infiltration of plasmacytomas.
✓. Patients with one prior line of therapy must have:
✓. Age ≥ 18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Note: for patients with central nervous system (CNS) involvement, an ECOG performance status \>2 is also acceptable
✓. Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
✓. Patient must have measurable disease of MM as defined by the below criteria:

Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria