Active — Not RecruitingPhase 2

Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma

Spain30 participantsStarted 2023-09-21

Plain-language summary

The goal of this Phase 2, open-label, multicenter, non-randomized pilot study is to evaluate the efficacy (in terms of MRD negative CR rate after Intensification therapy) and safety of Tec-Dara (Teclistamab+Daratumumab) and Tal-Dara (Talquetamab+Daratumumab) in de novo high-risk multiple myeloma (DNHRMM) patients.

Who can participate

Age range18 Years

SexALL

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

✓. High-risk FISH: del(17p), t(4;14), t(14;16) and 1q amplifications.
✓. R-ISS 3
✓. Presence of extramedullary disease, defined as presence of paramedullary lesions or extramedullary plasmacytoma.

Exclusion criteria

✕. Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignancy or low grade, \< 3 cm, no carcinoma in situ).
✕. Skin cancer (non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone).
✕. Noninvasive cervical cancer.
✕. Localized prostate cancer (M0, N0) with a Gleason score of ≤ 7a, treated locally only (radical prostatectomy/radiation therapy/focal treatment).
✕. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
✕. Other malignancy that is considered cured with minimal risk of recurrence.

What they're measuring

Evaluate efficacy in terms of Measurable Residual Disease (MRD) negative Complete Remission rate by Next Generation Flow Cytometry after Teclistamab plus Daratumumab intensification.

Timeframe: 22 months approximately

Evaluate efficacy in terms of Measurable Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan using the Deauville score, after Tec-Dara intensification.

Timeframe: 22 months approximately

Trial details

NCT IDNCT05849610

SponsorPETHEMA Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-03

View on ClinicalTrials.gov More High-Risk de Novo Multiple Myeloma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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

✓. High-risk FISH: del(17p), t(4;14), t(14;16) and 1q amplifications.
✓. R-ISS 3
✓. Presence of extramedullary disease, defined as presence of paramedullary lesions or extramedullary plasmacytoma.

Exclusion criteria

✕. Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignancy or low grade, \< 3 cm, no carcinoma in situ).
✕. Skin cancer (non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone).
✕. Noninvasive cervical cancer.
✕. Localized prostate cancer (M0, N0) with a Gleason score of ≤ 7a, treated locally only (radical prostatectomy/radiation therapy/focal treatment).
✕. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
✕. Other malignancy that is considered cured with minimal risk of recurrence.

What they're measuring

Evaluate efficacy in terms of Measurable Residual Disease (MRD) negative Complete Remission rate by Next Generation Flow Cytometry after Teclistamab plus Daratumumab intensification.

Timeframe: 22 months approximately