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Clinical Trials/EUCTR2009-012417-22-DE
EUCTR2009-012417-22-DEActive, not recruitingNot Applicable

A phase II, multi-center, non-randomized, open-label study of TKI258 in patients with relapsed or refractory multiple myeloma, who are with or without t(4;14) translocation - N/A

ovartis Pharma Services AG0 sites80 target enrollmentStarted: February 17, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
80
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
  • •2. Evidence of relapsed or refractory disease as documented from the prior treatment history (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1).
  • •3. Have received at least 2 prior treatment regimens for multiple myeloma including
  • •chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction followed by transplant and maintenance should be
  • •considered as one regimen.
  • •4. Presence of measurable disease as defined by at least one of the following;
  • •Serum M-protein = 1g/dL (measurable disease)
  • •Urine M-protein = 200mg/24 hours by protein electrophoresis (measurable disease)
  • •5. Age = 18 years.
  • •6. WHO (World Health Organization) performance status of = 2.
  • •7. Must have the following baseline laboratory values;
  • •Absolute neutrophil count = 1000/mm3 (or = 750/mm3 if neutropenia is clinically
  • •related to progressive myeloma with bone marrow infiltration) [SI units, 1.0x109/L,and 0.75x109/L, respectively)
  • •Platelet count = 75,000/mm3 (or = 50,000/mm3 if thrombocytopenia is clinically
  • •indicated to progressive myeloma with bone marrow infiltration) [SI units, 75x109/L,and 50x109/L, respectively) (transfusion support allowed)
  • •Hemoglobin (Hgb) = 8 g/dl (transfusion support allowed)
  • •AST and ALT = 3.0 x ULN
  • •Serum bilirubin = 1.5 x ULN
  • •Electrolyte levels = LLN (i.e., potassium, magnesium, phosphorus), correction with
  • •supplements allowed
  • •Serum creatinine = 2.0 x ULN (or 24-hour creatinine clearance = 50 ml/min)
  • •8. Willing and able to undergo bone marrow aspirations and bone marrow biopsies as per the study center’s practice and protocol requirements.
  • •9. Life expectancy of =12 weeks.
  • •10. Must provide written informed consent to participate in this study.
  • •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
  • •F.1.3 Elderly (>=65 years)
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Patients with non-secretory, or oligosecretory, multiple myeloma.
  • •2. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
  • •3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versushost
  • •disease that requires immunosuppressive therapy.
  • •4. Patients with history of another malignancy within the last three years prior to study entry, except cured basal
  • •cell carcinoma of the skin or excised carcinoma in situ of the cervix.
  • •5. Patients who have received the last administration of anticancer therapy (for example chemotherapy,
  • •immunotherapy, hormonal therapy, and targeted therapy, but except nitrosourea, mitomycin-C, and anti-cancer
  • •monoclonal antibody), less than 2 weeks prior to the start of study drug, and who have not recovered from the
  • •side effects of such therapy. Patients who have received the last administration of nitrosourea, mitomycin-C = 6
  • •weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
  • •6. Patients who received the last administration of an anti-cancer monoclonal antibody = 6 weeks prior to starting
  • •study drug, or who have not recovered from the side effects of such therapy.
  • •7. Patients who have received any other investigational agents = 4 weeks prior to starting study drug or who have
  • •not recovered from the side effects of such therapy.
  • •8. Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium
  • •89) = 4 weeks or limited field radiation for palliation = 2 weeks prior to starting study drug or who have not
  • •recovered from side effects of such therapy.
  • •9. Patients who have undergone a major surgery = 2 weeks prior to starting study drug or who have not recovered
  • •from side effects of such therapy.
  • •10. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • •History or presence of serious uncontrolled cardiac arrhythmias
  • •Clinically significant resting bradycardia
  • •LVEF assessed by 2-D echocardiogram < 50% or lower limit of normal (whichever is higher) (ECHO) or
  • •Multiple gated acquisition scanning (MUGA) < 45 % or lower limit of normal (which ever is higher)
  • •11. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable
  • •angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident
  • •(CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
  • •12. Uncontrolled hypertension defined by SBP =160 mmHg and/or DBP =100 mmHg, with or without antihypertensive
  • •medication(s). Initiation or adjustment of antihypertensive medication(s) is allowed prior to study
  • •13. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of
  • •TKI258 (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small
  • •bowel resection).
  • •14. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).
  • •15. Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin.
  • •16. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled
  • •infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • •17. Pregnant or breast-feeding women.
  • •18. Male, and female patients of child-bearing potential, who are biolo

Investigators

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