Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma

Celgene73 sites in 4 countries46 target enrollmentApril 30, 2014

ConditionsMultiple Myeloma

InterventionsLenalidomide

DrugsLenalidomide

Overview

Phase: Phase 3
Intervention: Lenalidomide
Conditions: Multiple Myeloma
Sponsor: Celgene
Enrollment: 46
Locations: 73
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma.

After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.

Detailed Description

The planned total number of evaluable subjects for PFS was approximately 351 (234 in the lenalidomide treatment arm; 117 in the placebo treatment arm) and the study will be conducted in European countries. However, due to the significant enrollment challenges and the changes in the NDMM treatment practices in subjects who are not eligible for transplant, such as the recent approval of Revlimid in NDMM setting, the DMC recommended to close study enrollment. Study enrollment was closed on 12 October 2015.

Registry

clinicaltrials.gov

Start Date

April 30, 2014

End Date

October 12, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
•Related to initial diagnosis and prior Melphalan Prednisone Velcade (MPV) induction therapy
•Previously untreated and symptomatic multiple myeloma.
•All 3 criteria (Durie, 2003) and at least one of the Creatinine Renal insufficiency Anemia lytic Bone lesions or osteoporosis criteria must be met.
•Measurable disease by protein electrophoresis analyses.
•All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least Partial Response as best overall response and maintained at Melphalan Prednisone Velcade discontinuation. If a subject achieves Complete Response prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise.
•Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6-9 cycles of induction therapy with Melphalan Prednisone Velcade.
•Subjects must have cytogenetic (17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (International Staging System) results from their initial diagnosis available at the time of screening.
•Related to the subject
•Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures,

Exclusion Criteria

•The presence of any of the following will exclude the subject from the study enrollment:
•Previous treatment with anti-myeloma therapy other than the required 6-9 cycles of Melphalan Prednisone Velcade induction therapy (does not include local radiotherapy, bisphosphonates, or a single short course of steroid \[ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization\]).
•Subjects who didn't achieve Partial Response or better after getting at least 6 cycles of Melphalan Prednisone Velcade and at the end of Melphalan Prednisone Velcade whatever the overall response are not eligible.
•Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or desoxyribonucleic acid modulating agents. Subjects who received investigational agents are also excluded.
•Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
•Pregnant or lactating females.
•Any of the following laboratory abnormalities:
•Absolute neutrophil count \< 1,000/L (1.0 x 10\*9/L) Untransfused platelet count \< 50,000 cells/L (50 x 10\*9/L) Serum glutamic oxaloacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase \> 3.0 x upper limit of normal Serum bilirubin levels \> 1.5 x upper limit of normal
•Renal insufficiency (creatinine clearance \< 30 mL/min by Cockcroft-Gault method) or actual creatinine clearance result, or renal failure requiring hemodialysis or peritoneal dialysis.

Arms & Interventions

Lenalidomide

Treatment Arm A: lenalidomide 10 mg/day orally from Days 1 to 21; given in 28-day cycles for up to disease progression.

Intervention: Lenalidomide

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Approximately 6 years

Is defined as the time from the date of randomization to the date of death due to any cause.

Secondary Outcomes

Safety; Adverse Events (AE) [type, frequency, and severity of AEs, and relationship of AEs to investigational product (IP) SAEs, laboratory abnormalities, hospitalizations, and SPMs(Approximately 6 years)