Phase
Condition
Multiple Myeloma
Leukemia
Lymphoproliferative Disorders
Treatment
Bortezomib
Dexamethasone
Daratumumab
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 years of age to 70 years of age, inclusive
Have an ECOG performance status score of 0 to 2 at screening
Have clinical laboratory values meeting prespecified criteria during the ScreeningPhase.
Participants in Arms A, A1, B, D, E, E1, F and F1 must also satisfy all of the following criteria to be enrolled in the study:
Documented multiple myeloma requiring treatment as defined by the criteria below:
Multiple myeloma diagnosis according to the IMWG diagnostic criteria
Measurable disease at screening as defined by any of the following:
Serum M-protein level ≥1.0 g/dL or
Urine M-protein level ≥200 mg/24 hours or
Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum freelight chain ratio
Newly diagnosed participants for whom HDT and ASCT is part of the intendedtreatment plan (except Arm D participants). Participants Arm C and C2 must also satisfy all of the following criteria:
Newly diagnosed multiple myeloma according to IMWG criteria.
Must have received 4 to 6 cycles of 3 or 4 drug-induction therapy that includesa proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonalantibody and a single or tandem ASCT. Post-ASCT consolidation is permitted forup to 2 cycles as long as the total number of induction plus consolidationcycles does not exceed 6.
3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 without evidence of progression at the time of enrollment.
- Must have received HDT and ASCT within 12 months of the start of inductiontherapy and be within 6 months of the last ASCT (7 months for participants whoreceived consolidation) at the time of enrollment.
Exclusion
Exclusion Criteria:
CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
Stroke or seizure within 6 months prior study start Cycle1 Day1.
History of transplantations requiring immunosuppressive therapy.
Seropositive for HIV, HEP B, Active Hep C infection (details see protocol).
COPD with a FEV1 <50% of predicted normal.
Moderate /severe persistent asthma within the past 2 years or any uncontrolledasthma. Exclude if FEV1 <50% of predicted normal.
Concurrent medical or psychiatric condition or disease that is likely tointerfere with study procedures, or that in the investigators opinion wouldconstitute a hazard for participants.
Contraindications or life-threatening allergies, hypersensitivity, orintolerance to any study drug/excipients.
Pregnant, breastfeeding, or planning to become pregnant while enrolled in thisstudy or within 6 months after the last dose of any study treatment regimen.
Plans to father a child while enrolled in this study or within 100 days afterthe last dose of any component of the study treatment regimen. Arm A, A1, B, D, E, E1, F, F1
Prior or current systemic therapy or stem cell transplant for any plasma celldyscrasia, with the exception of emergency use of a short course (equivalent ofdexamethasone 40 mg/day for a maximum 4 days) of corticosteroids beforetreatment.
Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher asdefined by the NCI-CTCAE Version 5. Due to a potential interaction with bortezomib, received a strong CYP3A4 inducerwithin 5 half-lives prior to enrollment Arm C and C2
Discontinued treatment due to any AE related to lenalidomide as determined bythe investigator.
Progressed on multiple myeloma therapy at any time prior to screening.
Received a cumulative dose of corticosteroids equivalent to ≥40 mg ofdexamethasone within the 14 day period before the start of study treatmentadministration.
Intolerant to the starting dose of lenalidomide (10 mg). For further details on inclusion/exclusion criteria please refer to the studyprotocol.
Study Design
Study Description
Connect with a study center
Charité University Medicin Berlin
Berlin, 12203
GermanyActive - Recruiting
Clinic Chemnitz gGmbH
Chemnitz, 09113
GermanyActive - Recruiting
University Clinic Technical University Dresden
Dresden, 01307
GermanyActive - Recruiting
University Clinic Düsseldorf
Düsseldorf, 40225
GermanyActive - Recruiting
University Clinic Freiburg
Freiburg, 79106
GermanyActive - Recruiting
Asklepios Clinic Hamburg Altona
Hamburg, 22763
GermanyActive - Recruiting
Hamburg University Clinic Eppendorf
Hamburg, 20246
GermanyActive - Recruiting
University Hospital Heidelberg
Heidelberg, 69120
GermanyActive - Recruiting
University Clinic Schleswig-Holstein Campus Kiel
Kiel, 24105
GermanyActive - Recruiting
Technical University Munich
Munich, 81675
GermanyActive - Recruiting
University Würzburg
Würzburg,
GermanyActive - Recruiting
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