Randomisierte Phase III Studie für Patienten mit Multiplem Myelom zur Untersuchung zweier Therapieschemata einer Bortezomib-basierten Induktionsthearpie und einer Lenalidomid-Konsolidierungstherapie gefolgt von einer Erhaltungstherapie mit Lenalidomid

Phase 1

• Conditions: multiple myeloma (symptomatic, newly diagnosed); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-019173-16-DE
• Lead Sponsor: niversity Hospital Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-23
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 604

Inclusion Criteria

• newly-diagnosed symptomatic multiple myeloma (CRAB criteria)
• measurable disease
• age 18 - 70 years (both included)
• WHO performance status 0-2 (WHO=3 is allowed when caused by myeloma)
• negative pregnacy test
• patients must be willing and capable to use adequate contraception
• 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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

• hypersensitivity to any relevant medication within the trial
• systemic AL-amyloidosis
• previous chemotherapy or radiotherapy during the past 5 years
• severe cardiac dysfunction
• significant hepatic dysfunction
• patients known to be HIV-positive
• other malignancy during the past 5 years
• peripheral neuropathy CTC grade 2 or higher

Study & Design

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