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Brief Title: Selinexor, Cyclophosphamide and Prednisone in Myeloma
Official Title: A Randomised Phase II Trial of Selinexor, Cyclophosphamide and Prednisone vs Cyclophosphamide and Prednisone in Relapsed or Refractory Multiple Myeloma (RRMM) Patients
Study ID: NCT06212596
Brief Summary: The trial is designed as a randomised, controlled, open, parallel group, multi-centre phase II trial to evaluate clinical efficacy of selinexor in combination with cyclophosphamide and prednisone.
Detailed Description: The trial is designed as a randomised, controlled, open, parallel group, multi-centre phase II trial to evaluate clinical efficacy of selinexor in combination with cyclophosphamide and prednisone. Selinexor is the first-in-class selective inhibitor of nuclear export (SINE). Selinexor forms slowly reversible adducts with the substrate binding pocket of Exportin and has been demonstrated to lead to effective cell kill by causing accumulation pro-apoptotic proteins in the nucleus of myeloma cells. To maximise response to this novel drug in a relapsed-refractory setting, Selinexor will be combined with low-dose cyclophosphamide and prednisone. Lower, continuous doses of cyclophosphamide and intermittent doses of prednisone have been chosen to limit toxicity for the triplet regimen in the elderly myeloma patient population. A calibration group will receive cyclophosphamide plus prednisone alone, and will be used to evaluate the validity of the outcome in the experimental group. Participants will be randomised on a 3:1 basis to receive either selinexor + cyclophosphamide + prednisone (SCP) or cyclophosphamide + prednisone (CP). A maximum of 60 participants will be recruited (45 participants in the SCP arm, and 15 participants in the CP arm). Participants who experience disease progression on the CP arm, may receive SCP, once progression has been confirmed by the CTRU and the participant has been deemed eligible to receive SCP. Patients randomised to SCP have no further trial treatment stipulated following SCP therapy. The analysis of the treatment switch phase of the trial is exploratory. Participants will be recruited from approximately 10 NHS Hospitals throughout the UK.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
St Bartholomew Hospital, London, , United Kingdom
Guys and St Thomas NHS Foundation Trust, London, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
James Cook University Hospital, Middlesbrough, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Sheffield, , United Kingdom
University Hospital Southampton, Southampton, , United Kingdom
Royal Stoke University Hospital, Stoke-on-Trent, , United Kingdom
Worthing Hospital, Worthing, , United Kingdom
Name: Martin Kaiser
Affiliation: Institute of Cancer Research, United Kingdom
Role: PRINCIPAL_INVESTIGATOR