A National, Open-label, Multicenter, Randomized, Comparative Phase IIb 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 (Rd).
65 Years
N/A
Both
Multiple Myeloma
Trial Information
A National, Open-label, Multicenter, Randomized, Comparative Phase IIb 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 (Rd).
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 days (Days -14 to -1). If patients meet all inclusion and exclusion
criteria will be randomized at the moment of entry in the trial in a 1:1 allocation to
receive either MPV followed by Rd (Treatment Group A) or MPV alternating with Rd (Treatment
Group B).
Patients in the Treatment Group A will receive nine cycles of MPV consisting on one 6-weeks
cycle of Velcade (Bortezomib) as an intravenous bolus twice weekly (days 1, 4, 8, 11, 22,
25, 29 and 32) followed by a 10 day rest period (day 33 to 42), in combination with oral
Melphalan, once daily on days 1 to 4 and oral Prednisone, once daily on days 1 to 4,
followed by eight 4-weeks cycles of Velcade (Bortezomib) as an intravenous bolus on days 1,
8, 15 and 22 followed by a 6 day rest period (days 23 to 28), in combination with Melphalan
and Prednisone per os once daily on days 1 to 4, followed by a 24-day rest period (days 5 to
28). After the nine MPV cycles, patients will receive nine cycles of Rd consisting on
4-weeks cycles, including Revlimid (lenalidomide), once daily on days 1-21 followed by a 7
day rest period (days 22 to 28) plus oral dexamethasone, once weekly on days 1,8,15 and 22,
followed by a 6 day rest period (days 23 to 28).
Patients in the Treatment Group B will receive the same schedule of therapy, but the MPV
cycles will be alternated with Rd cycles. In this treatment Group B, patients will be again
randomized to start receiving either MPV or Rd as first cycle of therapy. Overall, patients
will receive an identical number of cycles, nine cycles of MPV and nine of Rd. Patients
randomized to Treatment Group A relapsing/progressing or with major toxicities under
treatment with MPV will be crossover to receive Rd, but only after study coordinator
approval.
During the Treatment Period, patients will be evaluated at day 1 of each cycle. After
completion of the Treatment Period, all patients will be evaluated every 2 months
thereafter.
Safety will be assessed by the monitoring of adverse events, physical examinations, vital
signs measurements, and haematology and clinical chemistry test. Response to treatment will
be based on EBMT an IMWG criteria. Response to treatment will be evaluated at day 1 of each
induction cycle, and every 2 months during thereafter.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Time Frame:
18 months
Safety Issue:
No
Authority:
Spain: Ministry of Health
Study ID:
GEM2010MAS65
NCT ID:
NCT01237249
Start Date:
March 2011
Completion Date:
November 2014
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Velcade
- Revlimid
- Multiple Myeloma
- Neoplasms, Plasma Cell
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