✦ Cancer Clinical Trials

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Myeloma

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Jul 13 – Jul 20, 2026

Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial.
NAT MED · Q1 JOURNAL - RANK #1/195TOP-TIER
This ongoing phase 2 GMMG-HD10/DSMM-XX (MajesTEC-5) trial prospectively evaluated teclistamab-based induction in transplant-eligible, newly diagnosed multiple myeloma, assigning 49 patients to Tec-DR (teclistamab/daratumumab/lenalidomide) or Tec-DVR (plus bortezomib) and following through induction, autologous transplant, and premaintenance. Primary endpoints were safety (AEs/SAEs), with secondary efficacy endpoints (ORR, MRD negativity, MRD-negative CR). Grade 3–4 TEAEs occurred in 91.8% (lymphopenia 59.2%, neutropenia 59.2%, leukopenia 18.4%); SAEs in 55.1%; infections in 81.6% (grade 3–4: 36.7%); CRS in 67.3% (all grade 1–2, resolved); no grade 5 TEAEs or treatment-related ICANS. Efficacy was notable with ORR 100% (49/49), MRD-negative CR 91.8% (45/49) by premaintenance, and 100% MRD negativity in evaluable samples at postinduction cycles and premaintenance, supporting the feasibility and high activity of Tec-D(V)R induction.
10.1038/s41591-026-04471-x

Continuous or Fixed-Duration Maintenance Therapy in Multiple Myeloma.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3 clinical trial aimed to compare the efficacy of indefinite-duration versus fixed-duration lenalidomide maintenance therapy in newly diagnosed multiple myeloma patients with standard risk, who were not undergoing up-front autologous stem-cell transplantation. A total of 516 patients were randomly assigned to either the indefinite-duration (260 patients) or fixed-duration (256 patients, 2 years of treatment) groups after induction therapy. At a median follow-up of 86 months, overall survival between the groups did not significantly differ (7-year survival: 68.6% vs. 69.0%, P=0.93), while progression-free survival at 7 years was slightly higher in the indefinite-duration group (36.1% vs. 29.7%). Indefinite-duration therapy was associated with a higher incidence of grade ≥3 nonhematologic adverse events (48.2% vs. 31.5%) and marginally higher rates of secondary primary cancers (11.2% vs. 8.3%).
10.1056/NEJMoa2600157

Jun 29 – Jul 06, 2026

Photobiomodulation to prevent oral mucositis and physical function impairments after hematopoietic cell transplantation: POMFITT randomized trial.
SUPPORT CARE CANCER · Q1 JOURNAL - RANK #17/173
The study evaluated the effectiveness of photobiomodulation versus standard care in preventing oral mucositis and functional impairment in 30 adults undergoing hematopoietic cell transplantation (HCT) for hematologic malignancies, using a randomized controlled trial design. The intervention involved InGaIP diode laser treatment (660 nm and 808 nm wavelengths, 100 mW, administered three times weekly from conditioning day 1 to day +3), with outcomes measured via WHO oral mucositis scale, 2-min step test, Jamar dynamometer, Sit-to-Stand test, and FACT-BMT. Severe oral mucositis occurred in 26.6% of controls versus 0% in the intervention group (p=0.032), but no significant differences were observed in hospitalization days, handgrip strength, aerobic capacity, or lower-limb strength. The study concluded that photobiomodulation reduced severe oral mucositis incidence without impacting physical function or quality of life, with high patient acceptance (93.3% rated 10/10).
10.1007/s00520-026-10970-x

Jun 15 – Jun 22, 2026

Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma.
CLIN PHARMACOL THER · Q1 JOURNAL - RANK #34/352
This phase 1 clinical trial aimed to select a patient-centric first-in-human (FIH) dose of forimtamig, a T-cell bispecific antibody, for relapsed/refractory multiple myeloma (RRMM) by employing novel ex vivo and in vitro minimal anticipated biological effect level (MABEL) methods. The study used assays with MM cell lines and fresh bone marrow samples to estimate starting doses (0.4 and 6 μg), with the actual FIH dose set at 6 μg. Clinical activity was observed at higher dose cohorts (18, 54, 162 μg), showing durable objective responses, and safety was demonstrated through Grade 1 cytokine release syndrome at the starting dose. The approach was accepted by regulatory authorities and is proposed as a model for future dose selection in early-phase oncology drug development.
10.1002/cpt.70366

Recognising disease progression in MGUS and smouldering myeloma: Biomarkers, symptom monitoring and imaging.
BRIT J HAEMATOL · Q1 JOURNAL - RANK #24/98
This prospective subanalysis of the TEAMM trial focused on 133 of 977 newly diagnosed multiple myeloma patients with known precursor disease (MGUS or SMM) to investigate biomarkers, imaging, and symptom monitoring while receiving prophylactic antibiotics for 12 weeks. The investigators found that 70% of these patients experienced significant rises in paraprotein levels before progression, only 29% reported new symptoms, and 25% had fractures despite active monitoring. Biomarkers were not sufficiently specific to predict fractures, and only 40% of those with vertebral fractures reported back pain. The authors conclude that current strategies reliant on patient-reported symptoms and monoclonal immunoglobulin levels face challenges in detecting imminent disease progression, underscoring the need for improved early recognition methods.
10.1111/bjh.70492

Jun 08 – Jun 15, 2026

Longitudinal mechanisms of response, resistance and relapse to teclistamab in multiple myeloma: results from MajesTEC-1.
HAEMATOLOGICA · Q1 JOURNAL - RANK #11/98
The study aimed to elucidate the immunological mechanisms underlying response, resistance, and relapse to teclistamab, a BCMA-directed bispecific antibody, in patients with relapsed/refractory multiple myeloma within the MajesTEC-1 clinical trial (NCT03145181/NCT04557098). Methodology involved collecting and analyzing baseline, on-treatment, and relapse bone marrow and peripheral blood samples to correlate immune profiles and BCMA antigen expression with clinical outcomes. Responders demonstrated increased T-cell activation and margination, while nonresponders showed elevated checkpoint marker expression and sustained proportions of immunosuppressive regulatory T cells; at relapse, there was higher expression of T-cell dysfunction markers and reduced BCMA receptor density. The findings emphasize the relevance of immune profiling in optimizing teclistamab efficacy, informing combination strategies, and guiding treatment sequencing.
10.3324/haematol.2026.300526

Jun 01 – Jun 08, 2026

Arlocabtagene autoleucel-a GPRC5D-targeted CAR T-cell therapy in heavily pretreated relapsed/refractory multiple myeloma.
BLOOD · Q1 JOURNAL - RANK #2/98TOP-TIER
Arlocabtagene autoleucel (arlo-cel) is a GPRC5D-targeted CAR T-cell therapy tested in a phase 1 dose-escalation/expansion study (NCT04674813) in heavily pretreated adults with relapsed/refractory multiple myeloma (RRMM). Participants (N=84, median of five prior regimens) received a single infusion of 25×106-450×106 CAR T cells, and primary endpoints were safety and maximum tolerated dose. Cytokine release syndrome occurred in 82% (mostly grade 1/2), one patient died of CRS, and no MTD was reached. After 16.1 months follow-up, overall response rate was 87% (53% complete responses), median progression-free survival was 18.3 months (95% CI, 11.8-21.9), and 1-year overall survival was 90%, indicating durable responses.
10.1182/blood.2025030750

May 25 – Jun 01, 2026

Efficacy and safety of durcabtagene autoleucel in a phase 1 trial for patients with relapsed/refractory multiple myeloma.
SCI TRANSL MED · Q1 JOURNAL - RANK #3/195TOP-TIER
Part A of a phase 1 trial (NCT04318327) prospectively evaluated durcabtagene autoleucel, a rapidly manufactured BCMA-directed CAR T therapy, in 55 patients with relapsed/refractory multiple myeloma with safety as the primary objective and efficacy/feasibility as secondary endpoints. Patients received a single infusion at one of four flat target doses after a median 24-day vein-to-vein time. The overall response rate was 98%, stringent complete response rate 55%, and minimal residual disease negativity 80% among evaluable patients (35/44); no unexpected safety findings or delayed neurotoxicity were observed. Immunophenotyping/transcriptomics showed a preserved stem-like phenotype, supporting initiation of a phase 2 trial (NCT05172596).
10.1126/scitranslmed.adx1799