This is a multicenter, single arm, open-label, Phase 2 study in mutiple myeloma with newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan. The study is evaluating a technique called Mass Spectrometry Minimal Residual Disease (MS-MRD) using blood samples and compares it with the minimal residual disease (MRD) technique using bone marrow samples.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Daratumumab will be administered via a subcutaneous injection (SC)
Bortezomib will be administered via a subcutaneous injection (SC)
Lenalidomide will be administered orally
Dexamethasone will be administered orally
Innsbruck Medical University
Innsbruck, Austria
NOT_YET_RECRUITINGOrdensklinikum Linz
Linz, Austria
RECRUITINGClinic Ottakring
Vienna, Austria
NOT_YET_RECRUITINGMedical University of Vienna
Vienna, Austria
NOT_YET_RECRUITINGProportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-consolidation.
The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.
Time frame: Up to 12 months
Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGS-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-induction.
The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.
Time frame: Up to 4 months and 2 weeks
Proportion (%) of agreement and disagreement in the MRD measurements in BM (by NGF-MRD) and in the MRD measurements in peripheral blood (by MS-MRD) at post-induction and post-consolidation.
The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.
Time frame: Up to 12 months
Proportion (%) of agreement and disagreement in the MRD measurements in BM by NGF-MRD and NGS-MRD at post-induction and post-consolidation.
The proportion (%) of agreement will be defined as the total number of concordant cases (i.e., MRD-positive by both techniques, MRD-negative by both techniques) versus the total number of cases with available results.
Time frame: Up to 12 months
MRD negativity rate BM-MRD and PB-MRD
To evaluate the MRD negativity rate achieved at any time up to the end of consolidation with BM based MRD techniques and with the MS-MRD technique
Time frame: Up to 12 months
ORR, VGPR or better, CR or better, sCR at post-induction, post-transplant, post-consolidation and overall.
ORR will be defined as the percentage of participants achieving confirmed PR or better (i.e., PR+VGPR+CR+sCR). The number and percentage of participants achieving ORR, VGPR or better, CR or better and sCR will be presented, post-induction, post-consolidation, post-transplant and overall.
Time frame: Up to 12 months
Effect of cytogenetic abnormalities (presence or not), R-ISS (1, 2 or 3), CTCs (number of cells per ml) on likelihood to develop MRD-negative disease (with MS, NGS and NGF) and the agreement between the different techniques.
Binary logistic regression will be used to identify factors associated with post-induction and post-consolidation MRD status (negative or positive) (as defined with NGS-MRD; NGF-MRD; MS-MRD; the most conservative method), in the MRD-evaluable Analysis Set. Odds ratios and respective 95% CIs will be estimated from univariable and multivariable models.
Time frame: Up to 12 months
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Universitätsklinikum Hamburg - Eppendorf
Hamburg, Germany
RECRUITINGKlinikum rechts der Isar (MRI) der Technischen Universität München Department of Internal Medicine III (Hematology/Oncology) Munchen
München, Germany
NOT_YET_RECRUITINGUniversity Hospital of Alexandroupolis
Alexandroupoli, Greece
RECRUITINGAlexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, Greece
RECRUITINGSt Savvas Cancer Hospital
Athens, Greece
RECRUITINGTheagenion Cancer Hospital
Thessaloniki, Greece
RECRUITING...and 21 more locations