NCT07649525Toboroz3. fázis
Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level
iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 15.
Rövid összefoglaló (regiszter, angolul)
iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1226 (tervezett)
- Első benyújtás
- 2026. jún. 2.
- Kezdés
- 2026. júl.
- Elsődleges befejezés
- 2033. jún.
- Fő szponzor
- University of Leeds
- Betegségek
- Mielóma multiplex
- NCT-szám
- NCT07649525
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 1226
- 2026. júl. és az elsődleges befejezés (2033. jún.) között
- 5 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Previous treatment for myeloma, except as specified in the protocol,
- Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,
- Received a stem cell transplant,
Más betegség
- Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or
- Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),
- Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and
Egyéb
- Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),
- Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,
- Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.
- Additional eligibility criteria for randomisation into iFIT1/iFIT2/iFIT3 pathways, as follows:
- Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and
- Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.
- Further exclusion criteria related to safety of interventions (iFIT1).
- Full inclusion and exclusion criteria are listed in the protocol.
Kiket keres a vizsgálat
- Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.
- Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,
- Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,
- Aged 18 years or greater,
- Able to provide full informed consent, and
- Prepared to comply with pregnancy prevention plan.
- Completed 6 cycles of DRd induction therapy after registering within the iFIT study,
- Able to provide full informed consent, and
- Prepared to comply with pregnancy prevention plan.
- Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),
- Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),
- Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),
- Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),
- Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),
- Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),
- Categorised as FRAIL according to the IMWG frailty index (iFIT2), and
- Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).
A regiszterben nem jelölt feltételek
- Eligibility criteria for registration:
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Bristol Haematology and Oncology Centre | Bristol | Egyesült Királyság | Toborzás még nem indult |
| Eastbourne District General Hospital | Eastbourne | Egyesült Királyság | Toborzás még nem indult |
| St James University Hospital | Leeds | Egyesült Királyság | Toborzás még nem indult |
| The Clatterbridge Cancer Centre - Liverpool | Liverpool | Egyesült Királyság | Toboroz |
| The Royal Marsden Hospital | London | Egyesült Királyság | Toborzás még nem indult |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.