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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 70 years of age, inclusive.
. Documented MM as defined by the criteria below:
. MM diagnosis according to IMWG diagnostic criteria (Appendix 3),
. Untreated MM requiring systemic therapy,
. Measurable disease at screening, as defined by any of the following:
. Have an ECOG performance status 0-2 (Appendix 5) at screening and immediately prior to the start of administration of study treatment.
. Have clinical laboratory values meeting the following criteria during the screening period. Refer to Section 5.4.3 for criteria prior to first dose.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the efficacy (MRD negativity at a level of 10-6) of Tec-DRd compared to DVRd after induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM
Timeframe: after 6 cycles (each cycle is 28 days) of induction/consolidation therapy and HD melphalan and ASCT (which occurs appr. 1 year after start of treatment), before start of maintenance therapy.
. Eligible for HD melphalan and ASCT (in the opinion of the investigator).
Exclusion criteria
. 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.
. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:
. 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.
. Noninvasive cervical cancer.
. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (antihormonal therapy is permitted).
. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (radical prostatectomy/radiation therapy/focal treatment).