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About
Randomized (2:1) multi-center open-label phase II trial. Patients with high-risk SMM will be enrolled on the study and treated with KRd combination (Cycles 1-9 carfilzomib 20/36 mg/m2, lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9) or Rd combination (Cycles 1-9 lenalidomide 25 mg, dexamethasone 20 mg cycles 1-4 and 10 mg cycles 5-9); followed by extended lenalidomide dosing (10 mg days 1-21 of a 28 day cycle for 24 cycles).
Full description
Background of the study:
A recent study has shown that intervention with the use of novel agents in smoldering myeloma (SMM) resulted in prolonged PFS and OS without significant toxicity. A more recent pilot study in high-risk smoldering myeloma using carfilzomib, lenalidomide in combination with dexamethasone resulted in 100% CR rate and 10 out of 12 patients reached MRD negativity. These studies formed the rationale to compare the efficacy and safety of carfilzomib, lenalidomide and dexamethasone vs. lenalidomide, dexamethasone, both followed by 24 months of lenalidomide maintenance in high-risk SMM.
This study is designed to compare 2 treatment modalities to find the optimal treatment in efficacy and safety for highrisk SMM, to define new risk stratifiers for outcome to treatment in SMM and to better understand the biology of SMM.
Objective of the study:
The primary objective of the study is :
To assess the progression-free survival rate of KRd versus Rd in patients with high-risk SMM
Secondary objectives:
Study design:
Randomized multi-center open-label phase 2 trial.
Study population:
Patients with high-risk SMM, age 18 years or older
Intervention (if applicable):
Patients will be treated with KRd combination 9 cycles a 28 days (carfilzomib , lenalidomide , dexamethasone) or Rd combination (lenalidomide , dexamethasone ); followed by extended lenalidomide dosing (for 24 cycles a 28 days).
Primary study parameters/outcome of the study:
Secundary study parameters/outcome of the study (if applicable):
Discomfort from venipuncture, bone marrow biopsy, and CT scan is minimal and of limited risk
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria
Exclusion criteria
Treatment with corticosteroids for other indications is permitted
Primary purpose
Allocation
Interventional model
Masking
58 participants in 2 patient groups
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Central trial contact
H. Zanders; A. Broijl, Dr.
Data sourced from clinicaltrials.gov
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