Status:
COMPLETED
Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy
Lead Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Conditions:
Multiple Myeloma
Eligibility:
All Genders
60-70 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
In arm A1, patients received 4 cycles of conventional induction therapy with anthracycline/dexamethasone-based regimens. Specified in the protocol were vincristine/doxorubicin/dexamethasone (VAD), ida...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT02288741
Start Date
August 1 2001
End Date
September 1 2012
Last Update
November 11 2014
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