GMMG-HD11/DSMM XXI/64007957MMY3010
ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Heidelberg Medical Center
About this trial
This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen.
A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern CooperativeOncology Group (ECOG) status 0-2 will be included.
The primary objective of the clinical trial:
To determine the efficacy of Tec-DRd compared to DVRd after 6 cycles of induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM.
Endpoint: Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.
Eligibility criteria
Qualifiers
18 to 70 years of age, inclusive.
MM diagnosis according to IMWG diagnostic criteria (Appendix 3),
Untreated MM requiring systemic therapy,
Have an ECOG performance status 0-2 (Appendix 5) at screening and immediately prior to the start of administration of study treatment.
Disqualifiers
Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM).
Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy.
Nonmuscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no carcinoma in situ).
Nonmelanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.
Trial design
Treatments tested in this trial
- Teclistamab
- Daratumumab
- Lenalidomide
- Bortezomib (B)
- dexamethsone
Treatment groups
399 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov