Status:
COMPLETED
Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
Janssen, LP
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This protocol is a national, multicenter, comparative, open-label, randomized trial comparing the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL versus. MEL-200). ...
Eligibility Criteria
Inclusion
- The patient must, in the opinion of the investigator, be capable of complying with all requirements of the trial
- Have signed the informed consent form
- Be between 18 and 65 years of age and a candidate for autologous stem cell transplant
- Have an ECOG Performance Status \> 2 (or 3 if the ECOG is due to myeloma)
- Newly diagnosed patient with symptomatic multiple myeloma based on standard criteria, who has not received any prior chemotherapy treatment for Multiple Myeloma.
- Patient must have measurable disease, defined by the following criteria:
- For secretory MM, measurable disease is defined by any quantifiable value of serum M-protein (IgG ≥ 10 g/L or IgA \> 5 g/L) and/or, when applicable, an excretion of light chain in urine ≥ 200 mg/24 hours.
- For oglio- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas, which is determined by clinical exam or radiographic techniques.
- Life expectancy \> 3 months.
- The patient must have the following laboratory values in the 21 days prior to initiation of treatment (day 1, cycle 1):
- Platelet count ≥ 100 x 109/L and absolute neutrophil count of ≥ 1.0 x 109/L Corrected serum calcium \< 14 mg/dL. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x the upper limit of normal (ULN).
- Total bilirubin within normal limits. Serum creatinine ≤ 2 mg/dL
- \- Women of childbearing potential and men (including vasectomized men whose partners are women of childbearing potential), must use two methods of contraception during the entire course of treatment, during dose interruptions and for up to three months after receiving the final dose
Exclusion
- Non-secretory myeloma without measurable plasmacytomas.
- Patients who have undergone prior treatment for multiple myeloma, with the exception of emergency treatment using steroid pulses, bisphosphonates, or radiotherapy received before beginning induction treatment.
- Peripheral neuropathy ≥ grade 2 in the 21 days prior to inclusion.
- Known hypersensitivity to bortezomib, boric acid, mannitol or lenalidomide.
- Patients that have received any investigational agent in the 28 days prior to inclusion in the study.
- Patients who have had a myocardial infarction in the six months prior to inclusion in this study or who are a class III or IV according to the New York Heart Association (NYHA) functional classification system, heart failure, unstable angina, uncontrolled ventricular arrhythmias or acute ischemia detected by electrocardiogram, or nervous system disorders.
- Patients currently enrolled in another clinical trial or receiving any type of investigational agent.
- Patients who are seropositive for HBV, HCV or HIV.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 16 2016
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT01916252
Start Date
September 1 2013
End Date
November 16 2016
Last Update
September 27 2017
Active Locations (74)
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1
Hospital Son Espases (Son Dureta)
Mallorca, Balearic Islands, Spain, 07010
2
Hospital Son Llátzer
Palma de Mallorca, Balearic Islands, Spain, 07198
3
Hospital Durán i Reynals - ICO L´Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, -08907
4
H. Althaia, Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain, 08243