Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1) or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was scheduled for all patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Melphalan

Criteria

Inclusion Criteria:

• Histological confirmed multiple myeloma stage II or III according to the classification of Salmon and Durie

• Aged between 60 and 70 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Signed and dated written informed consent

• No previous chemotherapy or not more than one cycle in total or previous chemotherapy of more than one cycle if paused for at least 6 months and not more than six cycles in total (arm A1 and A2 only)

• Ongoing primary chemotherapy of two to maximum six cycles (arm B only)

Exclusion Criteria:

• Multiple myeloma stage I according to the classification of Salmon and Durie without need of any therapy

• Aged under 60 or over 70 years

• ECOG performance status >2

• Previous chemotherapy of more than six cycles

• Informed consent missing

• Myocardial infarction within the last six months

• Cardiac dysrhythmia stage IV b according to the classification of Lown

• Heart failure >NYHA II according to the classification of the New York Heart Association (NYHA), left ventricular ejection fraction <50% in ECG

• Severe restrictive or obstructive pulmonary disease (diffusing capacity <60% under normal)

• Renal insufficiency including a serum creatinine level >2mg/dl if not caused by multiple myeloma and reversible

• Liver diseases combined with an elevation of transaminases and of bilirubin of three times above normal

• Severe infections (HIV, hepatitis B/C, syphilis etc. )

• Severe psychiatric disease

• Other not curative treated malignant tumor within the last five years

• Concurrent participation in other clinical studies

• Other not curative treated malignant tumor within the last five years