and fever during neutropenia) mucositis and febrile neutropenia
Conditions
Interventions
Subjects will be randomized between the intervention group (Arm A: anakinra
intravenously once daily, in dose defined in pilot study AFFECT-1), and the
control group (Arm B: placebo intravenously on
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged >=18 years - Diagnosed with multiple myeloma - Scheduled to receive an autologous SCT after myeloablative therapy with high-dose melphalan - Managed with a central venous catheter (triple- or quadruple lumen) - Is able and willing to participate - Has provided written informed consent - Has negative serology for active hepatitis B and C - Has negative serology for HIV - Has no known hypersensitivity to Escherichia coli derived products or any components of anakinra - Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation (during treatment with study medication), and for 30 days after the last dose.
Exclusion criteria
Exclusion criteria: - Inability to understand the nature and extent of the trial and the procedures required - Enrolment in any other investigational treatment study or use of an investigational agent during the stem cell transplantation (this means studies in multiple myeloma regarding induction or maintenance treatment are permitted). - Women who are pregnant or nursing - Diagnosed with amyloidosis or light-chain deposition disease - ALT or AST greater than 2.0 x upper limit of normal (ULN) of the local laboratories values. - Bilirubin levels greater than 2.0 x upper limit of normal (ULN) of the local laboratories values, except for benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome - Impaired renal function with eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Reduction of incidence of fever during neutropenia | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Incidence of mucositis-related fever - Maximum CRP level on day +9-10 - Daily mean CRP level - Intestinal mucositis as measured by the area-under-the-curve of reciprocal citrulline levels - Clinical mucositis as determined by the daily mouth and gut scores - Days with fever ((>= 38.2° C) - Days with fever (>= 38.5° C) - Mean daily morning temperature - Area under the curve of daily morning temperature - Incidence of bloodstream infections i.e. bacteremia - Type of bloodstream infections - Incidence of persistently positive blood cultures on day +4 - Quality of life according to the EORTC QLQ-C30 - Severity of fatigue as the score measured by the validated FACIT-Fatigue scale - Tumor response evaluation (100 days and 1 year) - Short term overall survival (100 days and 1 year) - Length of hospital stay in days - Use of systemic antimicrobial agents (incidence and duration) - Use of analgesic drugs (incidence and duration) - Use of total parenteral nutrition (TPN) (incidence and duration) | — |
Countries
Netherlands
Outcome results
None listed