SESAM

Onderzoeksgebied

Therapeutisch, Veiligheid

Inclusiecriteria: U mag meedoen als

1. Patient must understand and voluntary sign informed consent form and be able and willing to comply with the study protocol
2. Patient, male or female, must 18 years of age or older at the time of signing consent
3. Patient must have documented multiple myeloma (as defined by the IMWG criteria, see appendix 22.1)
4. Patients must have received prior treatment(s) of standard dose Dexamethasone in combination with lenalidomide or pomalidomide, either as monotherapy or in the maintenance phase of a proteasome or antibody containing regimen initiated for progressive disease and achieved a response (partial response (PR) or better) as defined by the IMWG criteria (see appendix 22.2) to at least one prior regimen with dexamethasone.
5. Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2 (see appendix 22.3).
6. Patient’s estimated life expectancy (in the opinion of the Investigator) must be ≥ 6 months.
7. Female patients are eligible to participate if they are not pregnant, not breastfeeding and one of the following conditions applies:
o Women of non-childbearing potential (WONCBP): patients who are postmenopausal for at least 12 months prior to the study treatment or patients who are surgically sterile.
Or
o Women of childbearing potential (WOCBP): patients who have a negative serum pregnancy test within 7 days prior to the study treatment and agree to complete abstinence or to use dual anticonception (a contraceptive with a failure rate of Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Acceptable methods of contraception, because of a failure rate of Oral hormonal contraceptives are related with increased risk of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and dexamethasone. The contraceptive effects can also decrease when combined with dexamethasone. Therefore oral hormonal contraceptives are not recommended as contraception during the study program.
8. Male patients are eligible to participate if they agree to practice to cohere to the following conditions:
o Patients must practice true abstinence or agree to use contraception during the study period and through 90 days after the last dose of the study treatment when their sexual partner is a WOCBP. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Vasectomy is no exception to this condition.
o Patients must refrain from donating sperm during study drug therapy and for a period of 90 days after the last dose of the study treatment.

Exclusiecriteria: U mag niet meedoen als

1. Grade ≥2 hyperkalemia (serum concentration > 5,5mmol/l).
2. Grade ≥1 hyponatremia (serum concentration < 130mmol/l).
3. Renal failure requiring hemodialysis or peritoneal dialysis.
4. Patients with uncontrolled symptomatic hypotension.
5. Patients who are receiving thiazide or loop diuretics, because of the risk of hypotension.
6. Patients who are receiving potassium supplements.
7. Patients who are unable or unwilling to undergo antithrombotic therapy.
8. Patients with secondary Addison requiring glucocorticosteroid substitution with hydrocortisone.
9. Patients known with an active infection or with an infection within 14 days prior to the start of study treatment that required or requires the need of systemic antibiotics or hospitalisation.
10. Patients with severe and/or uncontrolled comorbidities, deemed by the investigator, to significantly interfere with study results of safety and tolerability.
11. Patients with history of inadequate compliance of standard of care treatment or with mental illness or social situation that would limit compliance with study requirement.

• UZ Gent