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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Teclistamab

    Drug

    TEC SC

  • Daratumumab

    Drug

    subcutaneous

  • Lenalidomide

    Drug

    oral administration

  • Bortezomib (B)

    Drug

    subcutaneous

  • dexamethsone

    Drug

    iv; po

Treatment groups

399 Participants
are divided into 3 treatment groups
Group A: Arm A DVRd induction (+ HDT ASCT), DVRd consolidation therapy followed by DR maintenanceActive comparator 4 interventions
Group B: Arm B - Tec-DRd induction ( incl. HDT ASCT) followed by DR maintenance therapy.Experimental treatment 4 interventions
Group C: Arm C - Tec-DRd induction (incl. HDT ASCT), followed by Tec-D then DR maintenance therapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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

Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.

Time frame
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.

Secondary outcomes

1

Sustained MRDnegative CR rate composite endpoint of events (death, progression, discontinuation of all treatments, Grade 3 or Grade 4 infections, and pause of more than 62 days of all study treatments).

1. Sustained (≥12 months) cumulative MRDnegative CR rate (10-6) by NGS up to 24 months of maintenance therapy. 2. Hierarchical composite endpoint of events (within 24 months of maintenance therapy), including death, progression, discontinuation of all treatments, Grade 3 or Grade 4 infections, and pause of more than 62 days of all study treatments.

Time frame
1) up to 24 months of maintenance therapy. 2) within 24 months of maintenance therapy
2

To determine response rates, MRD at a level of 10-5, best overall response and DOR, PFS, OS, stem cell harvest.

MRD at level 10-5 by NGS PFS DOR Time-to-next treatment (TTnT) OS Stem cell harvest QoL Best and overall response and CR rates before start of maintenance and up to 24 months of maintenance

Time frame
up to 24 months of maintenance

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Heidelberg Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: