Carfilzomib in combination with Thalidomide and Dexamethasone for remission induction and consolidation of Multiple Myeloma at first presentatio

Phase 1

Conditions: Multiple myeloma at first presentation
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-014922-40-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

·Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix I);
·Age 18-65 years inclusive;
·WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and
not by co-morbid conditions) (see appendix II);
·Negative urine pregnancy test at inclusion if applicable;
·Written informed consent.

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 145
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Known intolerance of Thalidomide;·Systemic AL amyloidosis;·Non-secretory MM;·Waldenstrom’s macroglobulinemia or IgM MM;·Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;·Severe cardiac dysfunction (NYHA classification II-IV, see appendix);·Significant hepatic dysfunction (serum bilirubin ³ 30 mmol/L or transaminases ³ 2.5 times normal level), unless related to myeloma;·Creatinine clearance (measured or calculated) <30cc/min·Alkaline Phosphatase >3x ULN·ANC < 1,0 x109/L, platelets < 75 x109/L, Hb < 4.9 mmol/L·Non-secretory MM defined as SPEP < 5 g/L and UPEP < 200 mg/24 hr·Intolerance to thromboprophylaxis;·Patients known to be HIV-positive;·Patients with active, uncontrolled infections;·Patients with neuropathy, CTC grade 3 or higher, or grade 2 painful peripheral neuropathy;·Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;·Patients (all males and all pre-menopausal women) who are not willing or capable to use adequate contraception during the therapy;·Lactating women;·WHO Performance status > 3.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the feasibility and efficacy of carfilzomib in combination with thalidomide and dexamethasone in patients with Multiple Myeloma at first presentation. ;Secondary Objective: - To investigate the clinical efficacy of carfilzomib in combination with thalidomide and dexamethasone for response in remission induction of Multiple Myeloma at first presentation. <br>- To investigate the clinical efficacy of carfilzomib in combination with thalidomide and dexamethasone for response in consolidation treatment of Multiple Myeloma at first presentation. <br>- To assess the stem cell harvest following carfilzomib in combination with thalidomide and dexamethasone<br>;Primary end point(s): Response (Complete response (CR), very good partial response (VGPR), overall response (OR)):After induction prior to HDM/ASCTAfter HDM/ASCT prior to consolidation treatmentAt end of consolidation treatment;Timepoint(s) of evaluation of this end point: after induction<br>after HDM/ASCT<br>after consolidation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy and toxicity of induction treatment;<br>Efficacy and toxicity of consolidation treatment;<br>Feasibility of good quality stem cell harvest;<br>Progression-free survival (PFS);<br>Overall Survival (OS).;Timepoint(s) of evaluation of this end point: These endpoints will be evaluated when applicable data for all patients<br>are available

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