Status and phase
Conditions
Treatments
About
The purpose of this study is to evaluate the effects of daratumumab monotherapy on bone disease in patients with relapsed/refractory MM who have received at least 2 prior lines of therapy, including lenalidomide and a PI.
Full description
This is a prospective, multicenter, non-comparative, open-label Phase II study. Daratumumab will be administered according to approved label. Approximately 57 subjects located in Greece will be enrolled in the study.
Patients shall receive treatment until disease progression, physician decision, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). Survival status and data of subsequent anti-myeloma treatment will be collected post-treatment.
Primary and secondary variables related to bone disease markers will be evaluated every other cycle of therapy. Disease evaluations will occur monthly and consist mainly of measurements of myeloma proteins. Other parameters may include bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin, and β2- microglobulin and albumin. Assessment of myeloma response and disease progression will be conducted in accordance with the modified IMWG response criteria
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males and females at least 18 years of age.
Voluntary written informed consent.
Subject must have documented relapsed or refractory multiple myeloma as defined by the criteria below:
a. Measurable disease as defined by any of the following:
Prior treatment with at least two lines of therapy including lenalidomide and a PI for MM (induction followed by any planned high dose therapy or consolidation or maintenance would be considered as one regimen).
Documented evidence of progressive disease as defined by the IMWG 2014 on or after the last regimen.
Karnofsky Performance Status score of ≥ 70.
All of the following laboratory test results during screening:
Adequate renal function (CrCl ≥ 30 mL/min by CKD-EPI).
Willingness and ability to participate in study procedures.
Reproductive Status:
Male patients must use a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy. They must also agree to follow instructions for methods of contraception for 4 weeks before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 3 months post-treatment completion.
Exclusion criteria
Patient has received any of the following therapies:
Clinically significant cardiac disease, including:
Chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
Known active hepatitis A, B, or C.
Known HIV infection.
Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrolment.
Hypersensitivity to the active substance or to any of the excipients.
Any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with subject's ability to give informed consent, the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
Pregnant or breastfeeding women.
Primary purpose
Allocation
Interventional model
Masking
57 participants in 1 patient group
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Central trial contact
Panayiotidis Panayiotis, Prof.
Data sourced from clinicaltrials.gov
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