A Phase I-IIa, Open label, Multi-Center, Dose Escalating Study to Evaluate the Safety of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate (Oncocort) as Monotherapy in Patients with Previously Treated Progressive Multiple Myeloma

Phase 1

• Conditions: Multiple Myeloma is a plasma cell malignancy that is characterized by accumulation of clonal plasma cells, mainly in the bone marrow, leading to clinical manifestations such as anemia, bone destruction, and renal insufficiency. Despite progress in our understanding of the disease and improvement in therapeutic options therapy remains palliative. Studies have shown improvement in mortality in the recent years, but the 5 and 10 year-estimated survival rate for myeloma patients remains rather low.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005137-32-DE
• Lead Sponsor: ENCELADUS Pharmaceuticals BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1.Previously diagnosed symptomatic MM according to International Myeloma Working Group (IMWG) criteria
a.Previously treated with at least two therapy lines including at least one proteasome-inhibitor and at least one immunomodulatory drug
b.Relapse after or progressive disease under last therapy according to IMWG criteria.
2.At least 18 years old
3.Measurable disease (M-protein and/or free light chains) in serum and/or urine
4.Willing and able to comply the study protocol visits and assessments
5.Willing to use highly effective methods of birth control
6.Written informed consent prior to study participation

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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1.Types of Multiple Myeloma previously shown to be irresponsive to dexamethasone monotherapy during the last 6 months
2.Plasma cell leukemia
3.Subject with positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive HIV antibody screen
4.Severe abnormal organ function or laboratory results at the time of the Screening Visit: WBC <3.0 g/L, ANC <1.5 G/L, PLT <50 G/L, Sodium <135 mmol/L or >150 mmol/L, potassium <3.5 mmol/L or >5.5 mmol/L, calcium <2.0 mmol/L or > 2.9mmol/L, phosphorus <0.8 mmol/L, total bilirubin >1.5x ULN, AP >2.5x ULN, gammaGT >3x ULN, ALT >3x ULN, CK >2.5x ULN, Creatinine >2x ULN, fasting glucose >250 mg/dL, albumin <3 g/dL, cholesterol >300 mg/dL
5.Treatment with oral or injectable (including intra-articular) corticosteroids (CS) within 4 weeks prior to Screening Visit. Inhaled and dermal corticosteroid formulations are allowed.
6.Subjects who have received a chemotherapeutic treatment cycle including dexamethasone within 4 weeks prior to the Screening Visit
7.Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to intravenous medications, biologic therapy or IV radiocontrast agents
8.Active infection requiring systemic treatment
9.Planned major surgery during the study period or had undergone major surgery within 30 days prior to the Screening visit.
10.Pregnancy or breastfeeding
11.Prior history of pulmonary embolism
12.Prior history of gastrointestinal hemorrhage
13.Prior history of a psychiatric disorder
14.Any clinically significant hepatic, renal, cardiac, pulmonary, gastrointestinal, metabolic or endocrine disturbances, other medical or psychiatric condition, or clinically relevant abnormal values on any investigation, in the opinion of the Investigator, that could make the subject unsuitable for the study, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study, including severe neuropathies or other painful conditions that might interfere with pain evaluation
15.Participation in another clinical investigation less than 4 weeks prior to inclusion
16.The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
17.The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study18.The subject is unwilling or unable to follow the procedures outlined in the protocol
19.The subject is mentally or legally incapacitated
20.Persons who are in a relationship of dependence to the Investigator or the Sponsor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified