GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Korábbi kezelés

• Stroke or seizure within 6 months prior study start Cycle1 Day1.
• Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures, or that in the investigators opinion would constitute a hazard for participants.
• Prior or current systemic therapy or stem cell transplant for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
• Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by the NCI-CTCAE Version 5.
  • Due to a potential interaction with bortezomib, received a strong CYP3A4 inducer within 5 half-lives prior to enrollment
  • Arm C and C2
• Progressed on multiple myeloma therapy at any time prior to screening.
• Received a cumulative dose of corticosteroids equivalent to ≥40 mg of dexamethasone within the 14 day period before the start of study treatment administration.

Más betegség

• History of transplantations requiring immunosuppressive therapy.
• Seropositive for HIV, HEP B, Active Hep C infection (details see protocol).
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug/excipients.

Egyéb

• CNS involvement or clinical signs of meningeal involvement of multiple myeloma.
• COPD with a FEV1 <50% of predicted normal.
• Moderate /severe persistent asthma within the past 2 years or any uncontrolled asthma. Exclude if FEV1 <50% of predicted normal.
• Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study 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 after the last dose of any component of the study treatment regimen.
  • Arm A, A1, B, D, E, E1, F, F1
• Discontinued treatment due to any AE related to lenalidomide as determined by the investigator.
• Intolerant to the starting dose of lenalidomide (10 mg).
  • For further details on inclusion/exclusion criteria please refer to the study protocol.

• 18 years of age to 70 years of age, inclusive
• Have an ECOG performance status score of 0 to 2 at screening
• Have an ECOG performance status score of 0 to 2 at screening and immediately prior to the start of administration of study treatment
  • Participants in Arms A, A1, B, D, E, E1, F, F1 and G 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 2. Urine M-protein level ≥200 mg/24 hours or 3. Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio 2. Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan (except Arm D and G 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 28-day cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6.
  • 3 Must have received only one line of therapy and achieved at least a PR as per IMWG 2016 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria for ≥PR based on repeat imaging utilizing the same modality 4. Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT (7 months for participants who received consolidation) at the time of enrollment.