The purpose of this study was to evaluate the effects of daratumumab with dexamethasone (DaraD) in subjects with relapsed or refractory multiple myeloma and renal impairment.
This was a multicenter, single arm, open-label phase 2 study. 38 subjects were enrolled to receive daratumumab and dexamethasone. Treatment cycles had a duration of 28 days. Subjects received treatment until either disease progression, death, unacceptable toxicity or for a maximum of 30 months. Drug administration and follow-up visits occurred more frequently for early cycles (weekly for the first 8 weeks, every two weeks for weeks 9-24 and then every 4 weeks). Disease evaluations occurred monthly and involved mainly measurements of myeloma proteins. Other assessments included bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin, and β2- microglobulin and albumin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \>75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
General Hospital of Athens "Alexandra"
Athens, Attica, Greece
The Evaluation of Progression Free Survival (PFS) in Subjects With Relapsed or Refractory Multiple Myeloma and Renal Impairment Treated With Daratumumab and Dexamethasone.
Progression free survival was defined as the time, in months, from treatment initiation (C1D1) to the date of the first documented disease progression or death due to any cause, whichever came first. Clinical deterioration was not considered progression. For patients who neither progressed nor died, the survival time was censored at the date of their last disease assessment. For patients who started a new anti-tumor treatment, survival time was censored at the date of the start of the new treatment.
Time frame: Duration from first daratumumab administration until death or last assessment, months.
Overall Response Rate (ORR)
Overall response rate was defined as the proportion of subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response.
Time frame: From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months)
Renal Response Rate (RRR)
Renal response rate was defined as the proportion of enrolled subjects who achieve a best response of renal partial response (PRRenal) or better using the IMWG criteria.
Time frame: From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months )
Duration of Response in Patients With RI
Duration of response was restricted to the subjects that achieve a best objective response of PR or better. It was measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).
Time frame: Assessed monthly from first dose of Daratumumab until PD or death from any cause (approximately up to 30 months)
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Time to Next Therapy
Time to next therapy was defined as the time, in months, from Cycle 1 Day 1 to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.
Time frame: From first dose until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 30 months)
Overall Survival
Overall survival was defined as the time, in months, from the first dose of therapy to the date of death from any cause.
Time frame: Time from first dose of study treatment to death (approximately up to 30 months)
To Assess the Safety and Tolerability of Daratumumab With Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma (RRMM) and Renal Impairment (RI).
The incidence of Adverse Events and Treatment Emergent Adverse Events in patients with refractory and relapsed multiple myeloma and renal impairment treated with daratumumab with dexamethasone was assessed according to the common Terminology Criteria for Adverse Events.
Time frame: Continuously throughout the study, starting from informed consent until 30 days after last study treatment (approximately up to 30 months).