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Astudiaeth achos: MonumenTAL-6

Astudiaeth sy’n cymharu effeithiolrwydd y cyffuriau Tal-pomalidomide (Tal-P) neu Tal-Tec pan gânt eu cymryd ar y cyd ag eraill i drin canser y gwaed.

Noddwr: Janssen-Cilag Rhyngwladol NV

Math o ganser Myeloma lluosog atglafychol neu anhydrin

Canser y gwaed yw myeloma lluosog sy’n effeithio ar rai mathau o gelloedd gwaed gwyn o’r enw celloedd plasma. Er bod triniaethau ar gael, gall myeloma lluosog ddychwelyd ar ôl triniaeth neu fod ag ymwrthedd i driniaeth safonol. Gall cyffuriau sy’n ailgyfeirio celloedd T (math o gelloedd gwaed gwyn) i ymosod ar gelloedd canser fod yn fodd effeithiol o ddinistrio celloedd canser gan arwain at ymateb triniaeth hirdymor.

Yn yr astudiaeth hon, mae ymchwilwyr eisiau dysgu am effeithiolrwydd y cyffuriau Tal-pomalidomide (Tal-P) neu Tal-Tec pan gânt eu cymryd ar y cyd ag eraill gan gynnwys elotuzumab, pomalidomide, a dexamethasone (EPd) neu pomalidomide, bortezomib, a dexamethasone (PVd).

Un ffordd o ganfod pa mor dda y mae triniaeth newydd yn gweithio yw mesur yr amser y mae’n ei gymryd i’r clefyd ddychwelyd neu waethygu. Bydd gan gyfranogwyr gyfle cyfartal o gael naill ai Tal-P neu Tal-Tec yn ogystal â thriniaeth EPd neu PVd a ddewisir gan feddyg yr astudiaeth. Astudiaeth label agored yw hon, sy’n golygu y bydd y cyfranogwr, y gofalwr, a meddyg yr astudiaeth yn gwybod am y cyffur astudio a roddir.

Mae’r treial hefyd yn galluogi cleifion y treial i gael mynediad at Talquetamab a teclistamab. Cyffuriau yw’r rhain sy’n defnyddio gwrthgyrff wedi’u haddasu i rwymo â phroteinau ar wyneb celloedd myeloma lluosog a chelloedd T, sy’n actifadu celloedd T ac yn lladd celloedd tiwmor.

“Myeloma is an expensive disease to treat but patients who become part of the trial will have their standard treatment and the trial drugs funded by Janssen Pharmaceuticals, meaning a significant saving to the NHS.

Although many new drugs have been approved to treat myeloma recently which can extend patient survival, Talquetamab is not available outside of trials and neither is the standard of care treatment (Elotuzumab-Pom-Dex). Therefore all patients recruited to this trial will benefit from treatment they could not access via the NHS and many will live longer as a result.”

Ceri Bygrave, Consultant Haematologist and Clinical Lead for Myeloma, University Hospital Wales

Cardiff Cancer Research Hub haematology expert Dr Ceri Bygrave wearing black jacket and cream shirt

“This trial demonstrates all the benefits of the Cardiff Cancer Research Hub. The collaboration has seen us upskilling the workforce, with research nursing working at both Velindre Cancer Centre and University Hospital Wales (UHW).

Janssen Pharmaceutical have been very supportive, providing joint training for Hub and UHW staff so we all have the skills and information needed to run this trial.”

Claire Lang, Senior Research Nurse Manager, Cardiff Cancer Research Hub

Full Study title: A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide