Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments thalidomide, bortezomib
Phase phase 3
Target proteasome
Sponsor Janssen Scientific Affairs, LLC
Start date January 2012
End date December 2015
Trial size 248 participants
Trial identifier NCT01539083, 26866138-MMY-2073, CR018751

Summary

The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Thalidomide consolidation and prednisolone maintenance therapy
thalidomide
Thalidomide: Type=1, unit=mg, number=100, form=tablet, route=oral use. Oral thalidomide consolidation will be administered for a maximum of 12 months or until disease progression along with Prednisolone: Type=1, unit =mg, number=50, form=tablet, route=oral use. Prednisolone maintenance therapy will be administered on alternate days continued indefinitely or until disease progression.
(Experimental)
Bortezomib + Thalidomide consolidation and prednisolone maintenance therapy.
bortezomib
Type=1, unit=mg/ml, number=2.5, form= Solution for injection, route=Subcutaneous use. Bortezomib will be administered as a single subcutaneous injection at a concentration of 1.3 mg/m2 every 2 weeks for 32 weeks (16 doses) in addition to 100 mg daily oral thalidomide consolidation for a maximum of 12 months or until disease progression and 50 mg oral alternate-day prednisolone maintenance continued indefinitely or until disease progression.
thalidomide
Type=1, unit=mg, number=100, form=tablet, route=oral use. 100 mg daily oral thalidomide consolidation (administered in addition to bortezomib) will be administered for a maximum of 12 months or until disease progression and 50 mg oral alternate-day prednisolone maintenance continued indefinitely or until disease progression.

Primary Outcomes

Measure
The number and percent of patients with complete response (CR) + very good partial response (VGPR)
time frame: After approximately 12 months of consolidation therapy

Secondary Outcomes

Measure
Complete response (CR) rate
time frame: From time of screening up to 12 months post-randomization
Stringent complete response (sCR) rate
time frame: From time of screening up to 12 months post-randomization
Progression-free survival (PFS) rate
time frame: From time of randomization up to 3 years post-randomization
Disease-free survival (DFS) rate
time frame: From time of randomization up to 3 years post-randomization
Overall survival (OS) rate
time frame: From time of randomization to up to 3 years post-randomization

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Previously diagnosed with multiple myeloma based on international myeloma working group (IMWG) criteria.and meet all of the following; Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter); Urine M-protein >=200 milligram (mg) per 24 hour and Serum Free Light chain (FLC) assay: Involved FLC Level >=10 mg/dL (>=100 mg/L) provided serum FLC ratio is normal - Meet the pretreatment laboratory criteria as specified in the study protocol at and within 21 days before baseline (Day 1 of Cycle 1, before bortezomib administration for induction). - Have ECOG status 0-2. - Men and women must practice an appropriate method of birth control as specified in the study protocol from signing of the informed consent form though to the 12-month visit/early termination visit. Exclusion criteria: - Has previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone) as specified in the study protocol. - Has a history of any other malignancy within 5 years before enrolment as specified in the study protocol. - Has had major surgery as specified in the study protocol within 30 days before enrolment. - Had a myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (or other clinically significant cardiac medical history as specified in the study protocol). - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.

Additional Information

Official title An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant
Description This is an open-label (patients will know the identity of study treatments), randomized (patients will be assigned by chance to different treatments) study of bortezomib administered as consolidation therapy (therapy given once a remission is achieved) with thalidomide and prednisolone versus thalidomide and prednisolone alone in previously untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells, a type of white blood cell present in your bone marrow. Patients in this study will receive initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure where patients receive an infusion of immature blood cells [stem cells] from their own body to replenish the body's supply of healthy blood-forming cells) before randomization to one of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression and prednisolone on alternate days continued indefinitely or until disease progression) or Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until disease progression and prednisolone on alternate days, continued indefinitely or until disease progression. Throughout the study, the patient's response to therapy will be assessed according to protocol-defined efficacy evaluations and by implementing defined disease response criteria (International Myeloma Working Group [IMWG] criteria). Safety will be evaluated throughout the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be conducted from time of randomization to 3 years post-randomization. Two interim analyses are planned. The final analysis will be conducted after all patients have completed 12-month consolidation treatment phase or discontinued. The primary endpoint of number and percent of patients with complete response and very good partial response defined by IMWG criteria for multiple myeloma will be examined in the interim and final analyses after approximately 12 months of consolidation therapy. At the completion of the study, updated analyses of PFS and OS will be performed.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen Scientific Affairs, LLC.