Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Phase 1

• Conditions: Relapsed/Refractory Multiple Myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000054086; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-005008-24-ES
• Lead Sponsor: FUNDACIÓN PETHEMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Age = 18 years
2. Performance status (ECOG) < 2.
3. Patient is, in the investigator’s opinion, willing and able to comply with the protocol requirements.
4. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
5. Patients previously diagnosed with MM according to the IMWG criteria (Lancet Oncology 2014) that after previous treatment with 1-3 regimens require therapy due to a relapse/progression of the disease.
6. Patients must have measurable disease, defined as follows:
• Serum monoclonal protein value = 0,5 g/L, or
• Urine light-chain excretion of = 0,2 g/24 hours, or
• Abnormal serum free light chains (FLCs) plus involved FLC level = 100 mg/L
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Primary refractory patients defined as not having achieved at least a PR with a prior therapy.
2. Refractoriness to prior proteasome inhibitor therapies, defined as not having achieved at least MR or having progressed under treatment or in the first 60 days after the last dose of the proteasome inhibitor.
3. Non adequate haematological or biochemical parameters as specified below:
• Hemoglobin <8.0 g/dL.
• Platelets count <75x109/L without previous platelet transfusions in the last 7 days. If high bone marrow infiltration (>50%) is present, =50x109/L platelet count is required.
• Absolute neutrophil count (ANC) <0.75 x109/L without previous G-CSF support in the last 7 days.
• Aspartate transaminase (AST): >2.5 x the upper limit range.
• Alanine transaminase (ALT): >2.5 x the upper limit range.
• Total bilirubin: >2 x the upper limit range.
• Calculated or measured creatinine clearance: <30 mL/min (calculated from the Cockcroft and Gault formula)
4. Left ventricular ejection fraction <50%.
5. Absence of recovery from any significant non-haematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
6. Pregnant or lactating women; men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).
7. Previous history of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site).
8. Other relevant diseases or adverse clinical conditions:
• Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
• Uncontrolled arterial hypertension or cardiac arrhythmias (i.e. requiring a change in medication within the last 3 months or a hospital admission within the past 6 months).
• History of significant neurological or psychiatric disorders.
• Active infection.
• Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
9. Patient is known to be human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or to suffer active hepatitis C infection.
10. Concomitant anti-myeloma therapy within 14 days prior to Day 1 of Cycle 1.
11. Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
12. Uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).

Study & Design

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