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