Status:
COMPLETED
Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone
Lead Sponsor:
PETHEMA Foundation
Collaborating Sponsors:
Janssen-Cilag Ltd.
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This is a national, multicenter, open-label, randomized, comparative study designed to compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV alternating with Rd) in ...
Detailed Description
The Pre-treatment period includes Screening visit. After providing written informed consent form to participate in the study, patients will be evaluated for eligibility during a screening period of 14...
Eligibility Criteria
Inclusion
- Written informed consent obtained before starting any study-specific procedure.
- Symptomatic elderly MM newly diagnosed by EBMT criteria older than 65 years.
- Performance status (ECOG) ≤ 2.
- Have pre-treatment clinical laboratory values meeting the following criteria within 14 days of randomization:
- platelet count ≥ 75x109/L
- haemoglobin ≥ 8g/dL
- absolute neutrophil count (ANC) ≥ 1.0x109/L
- Serum bilirubin ≤ 1.5 mg/dL and alkaline phosphatise ≤ 2.5 x ULN AST, ALT ≤ 2.5 x ULN
- Serum creatinine ≤2,5 mg/dl
Exclusion
- Patient previously received treatment with Velcade or Revlimid.
- Patient previously received treatment for Multiple Myeloma.
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrolment.
- Patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.
- Patient has received other investigational drugs with 28 days before enrolment.
- Patient had a myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
- Radiation therapy within 30 days before randomization, at least patient has had antialgic radiation. Radiation therapy will be afterwards permitted during the treatment period if it is indicated due to the presence of plasmacytomas
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01237249
Start Date
February 1 2011
End Date
May 1 2016
Last Update
January 18 2017
Active Locations (63)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
2
H. Vall d'Hebron, Barcelona
Barcelona, Barcelona, Spain
3
ICO - Duran i Reynals, Hospitalet de Llobregat
Barcelona, Barcelona, Spain
4
Hospital General de Castellón
Castellon, Castellón, Spain