A Phase 2 interventional study of Anakinra and Placebos in Multiple Myeloma, sponsored by Radboud University Medical Center. Completed at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Radboud University Medical Center · Phase 2, Interventional, and Supportive care
Oral and intestinal mucositis are major risk factors for the occurrence of fever during neutropenia and bloodstream infections after intensive chemo- and radiotherapy. These complications often require dose reductions or cause delay of treatment, and thereby interfere with optimal anticancer treatment. Currently, there are no effective strategies to prevent or treat mucositis and the related complications.
The pro-inflammatory cytokine interleukin-1β (IL-1β) has shown to be pivotal in the pathogenesis of mucositis and recently, it has been established in murine models that IL-1 inhibition significantly ameliorates chemotherapy-induced intestinal mucositis.
The investigators recently conducted a phase IIa study (AFFECT-1, NCT03233776) studying the safety and maximum tolerated dose of anakinra, a recombinant human IL-1 receptor antagonist in adult patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (ASCT) who are at high risk for experiencing mucositis and fever during neutropenia (FN).
Since treatment with anakinra has shown to be safe in this study population, the investigators will continue with a double-blind randomized placebo-controlled multicenter phase IIb trial to establish efficacy in the management of fever during neutropenia and mucositis.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 88 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dosage form: intravenous. Dosage: 300 mg. Frequency: once daily. Duration: 15 days (day -2 until day +12).
Drug: Anakinra
Dosage form: intravenous. Dosage: not applicable. Frequency: once daily. Duration: 15 days (day -2 until day +12).
Drug: Placebos
Subjects will be treated with a daily dose of 300 mg anakinra, intravenously, starting on day -2, until day +12 (day 0 is day of SCT).
Also known as: Kineret
Subjects will be treated with a daily dose of placebo, intravenously, starting on day -2, until day +12 (day 0 is day of SCT).
Reduction of the incidence of fever during neutropenia
Time frame: Primary outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Reduction in incidence of mucositis-related fever
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Daily mean CRP level
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Intestinal mucositis as measured by the area-under-the-curve of reciprocal citrulline levels
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Clinical mucositis as determined by the daily mouth and gut scores
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Days with fever (≥ 38.5° C)
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Incidence of bloodstream infections i.e. bacteremia
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Length of hospital stay in days
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Use of systemic antimicrobial agents (incidence and duration)
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Use of analgesic drugs (incidence and duration)
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Use of total parenteral nutrition (TPN) (incidence and duration)
Time frame: Outcome will be determined during the period of hospitalization (day of admission [day -3] until discharge, maximum period +30 days).
Quality of life according to the EORTC QLQ-C30
Quality of life according to the EORTC QLQ-C30
Time frame: Baseline, +30 days/discharge (whichever comes first), +100 days, +1 year
Fatigue severity according to the FACIT-Fatigue scale
Severity of fatigue as the score measured by the validated FACIT-Fatigue scale
Time frame: Baseline, +30 days/discharge (whichever comes first), +100 days, +1 year
Short term overall survival
Time frame: +100 days and +1 year
Tumor response evaluation
Time frame: +100 days and +1 year
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center