Myalgic Encephalomyelitis/Chronic Fatigue Syndrome MedDRA version: 20.1 Level: LLT Classification code 10028414 Term: Myalgic encephalomyelitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Darzalex
Pharmaceutical Form: Solution for injection
Sponsors
Haukeland University Hospital, Dept. of Oncology and Medical Physics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ME/CFS according to Canadian consensus criteria (2003) (1);moderate (mainly housebound) to severe (mainly bedridden) disease. Age 18 to 65 years. Signed informed consent. Duration of ME/CFS disease at least two years. The ME/CFS disease should have a defined onset, e.g. after an initial infection or other immunological trigger. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Chronic fatigue conditions not fulfilling Canadian consensus criteria. Age under 18 or over 65 years. Mild or mild-to moderate ME/CFS. Very severe ME/CFS, where patient is unable to travel to the hospital for intervention and assessments. Participation in a clinical trial with intervention aimed at ME/CFS during the last two years. Endogenous depression. Known multi-allergy with clinically assessed risk for hypersensitivity to daratumumab. Known contraindication to daratumumab. Significant comorbidity with reduced organ function (kidney, liver, heart, pulmonary). Previous long-term systemic treatment with immunosuppressants the last two years, excluding short steroid courses in e.g. obstructive lung disease. Chronic infections, including chronic hepatitis B or C, HIV, or other relevant infection. Previous or concomitant malignant disease, except basal carcinoma of the skin, or carcinoma in situ in the uterine cervix. Pregnancy or lactation. Inability to comply with protocol including follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose is to evaluate feasibility and safety of daratumumab subcutaneous injections in patients with moderate to severe ME/CFS. ;Secondary Objective: We will also collect efficacy data. ;Primary end point(s): The primary outcome measures are safety and tolerability as measured by treatment-emergent adverse events > CTCAE grade 1. ;Timepoint(s) of evaluation of this end point: Adverse events will be recorded bi-weekly during treatment period (weeks 12 to 20) and monthly until the end of study (52 weeks), and a total evaluation performed at end of study. A safety review will be performed after two patients have completed treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Descriptive endpoints: Changes from baseline/run-in through follow-up for: - SF36 domains including SF36 Physical Function (SF36-PF) and SF36 Bodily pain (SF36-BP) - DSQ-SF - Self-reported Function level - Steps per 24 hours. ;Timepoint(s) of evaluation of this end point: Baseline, end of run-in (12 weeks) and at 16, 18, 20, 22, 24, 28, 32, 40, 48 and 52 weeks. | — |
Countries
Norway
Contacts
Public ContactClinical trials coordinator
ME/CFS research group, Dept. of Oncology, Haukeland University Hospital
Outcome results
None listed