NCT07903272Toborzás még nem indult3. fázis
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
A Phase 3 Randomized Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) and Daratumumab and Lenalidomide (DR) Maintenance (DVRd + High-dose Therapy [HDT] + ASCT + DR) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 4.
Rövid összefoglaló (regiszter, angolul)
The purpose of this study is to compare how well Ramantamig plus Daratumumab (ramantamig-D) works compared with a treatment that includes Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd), followed by high-dose therapy, autologous stem cell transplantation (using the participant's own stem cells), and maintenance treatment with Daratumumab and Lenalidomide (DR) in participants with newly diagnosed multiple myeloma (NDMM), a blood cancer affecting plasma cells, who are eligible for transplant.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1000 (tervezett)
- Első benyújtás
- 2026. okt. 23.
- Kezdés
- 2026. dec. 14.
- Elsődleges befejezés
- 2037. jan. 11.
- Fő szponzor
- Janssen Research & Development, LLC
- Betegségek
- Mielóma multiplex
- NCT-szám
- NCT07903272
- EU CT-szám
- 2026-528315-27-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 1000
- 2026. dec. 14. és az elsődleges befejezés (2037. jan. 11.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Ki nem vehet részt
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Korábbi kezelés
- History of uncontrolled illness, including but not limited to: a. Acute diffuse infiltrative pulmonary disease, b. chronic obstructive pulmonary disease (COPD) with an forced expiratory volume in 1 second (FEV1) less than (<)50 percent (%) of predicted, c. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification, d. Evidence of active systemic viral, fungal, or bacterial infection requiring systemic antiviral, antifungal, or antimicrobial therapy, e. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of trial intervention. f. Disabling psychiatric conditions (for example, alcohol or drug abuse), severe dementia, or altered mental status, g. Stroke, transient ischemic attack, or seizure within 6 months prior to randomization, h. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 6.0
- Received any prior or current systemic therapy or stem cell transplant for any plasma cell dyscrasia, such as, but not limited to, smoldering MM, with the exception of emergency use of a short course of corticosteroids. Participants are allowed corticosteroids not exceeding greater than (>) 160 milligram (mg) of dexamethasone (or equivalent) within 14 days prior to trial intervention
- Received a strong cytochrome P450 (CYP3A4) inducer within 5 half-lives prior to randomization
- Concurrent use of any investigational agent within 30 days or 5 half-lives of the respective drug/investigational medicinal product (IMP) (whichever is longer) before randomization or currently enrolled in an investigational trial
- Radiotherapy on measurable soft tissue plasmacytoma(s) is not permitted even in the setting of palliation for symptomatic management. However, if the radiation is given for palliative purposes and the radiation portal covers less than or equal to (<=) 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy
Kiket keres a vizsgálat
- Have newly diagnosed multiple myeloma (NDMM) according to the international myeloma working group (IMWG) diagnostic criteria
- Be considered a candidate for high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) and commit to treatment with transplant. Transplant eligibility will be determined by the investigator per institutional standard of care, consistent with applicable regional guidelines
- Measurable disease as assessed by central laboratory at screening
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 2
- Participant must sign an informed consent form (ICF)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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