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

Phase 2

Completed

• Conditions: Multiple Myeloma; 10027656

• Registration Number: NL-OMON46962
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 145

Inclusion Criteria

- Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;
- 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);
- Negative urine pregnancy test at inclusion if applicable;
- Written informed consent.

Exclusion Criteria

- Known intolerance of Thalidomide;
- Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone
or local radiotherapy in case of local myeloma progression;
- Severe cardiac dysfunction;
- Creatinine clearance <30cc/min;
- ANC < 1,0 x109/L, platelets < 75 x109/L, Hb < 4.9 mmol/L;
- 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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To establish the response, in patients with Multiple Myeloma at first<br /><br>presentation, to carfilzomib in combination with thalidomide and dexamethasone. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the clinical efficacy and toxicity of carfilzomib in combination<br /><br>with thalidomide and dexamethasone in remission induction of Multiple Myeloma<br /><br>at first presentation.<br /><br>To investigate the clinical efficacy and toxicity of carfilzomib in combination<br /><br>with thalidomide and dexamethasone in consolidation treatment of Multiple<br /><br>Myeloma at first presentation.<br /><br>To assess the stem cell harvest following carfilzomib in combination with<br /><br>thalidomide and dexamethasone.<br /><br>To assess Progression-free survival (PFS).</p><br>