Overview

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 Revli

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
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 newly diagnosed MM patients older than 65 years. This comparison will be performing in terms of both efficacy and safety. Up to 120 patients will be included in each treatment arm and evaluated at scheduled visits in up to 3 study periods: Pre-treatment, Treatment and Follow-up. Primary outcome measure: - To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and Rd used as either in a sequential or alternating approach in newly diagnosed MM patients older than 65 years. - To evaluate the toxicity (safety and tolerability) of the sequential versus the alternating use of MPV and Rd. Secondary outcome measure: - To evaluate the response, duration of response, progression free survival (PFS), time to next therapy (TNT) and overall survival (OS) in the two different groups of patients. - To identify, within the group of patients treated with the alternating scheme, the biological characteristics (including a comprehensive genomic analysis) of those patients resistant to one or the other, and patients refractory to both treatments
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PETHEMA Foundation
Collaborators:
Celgene
Celgene Corporation
Janssen-Cilag Ltd.
TFS Trial Form Support
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Melphalan
Prednisone
Thalidomide
Criteria
Inclusion Criteria:

1. Written informed consent obtained before starting any study-specific procedure.

2. Symptomatic elderly MM newly diagnosed by EBMT criteria older than 65 years.

3. Performance status (ECOG) ≤ 2.

4. 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 Criteria:

1. Patient previously received treatment with Velcade or Revlimid.

2. Patient previously received treatment for Multiple Myeloma.

3. Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrolment.

4. Patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.

5. Patient has received other investigational drugs with 28 days before enrolment.

6. 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.

7. Patient currently is enrolled in another clinical research study and/or is receiving
an investigational agent for any reason.

8. 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