WHO ICTRP trial
A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib…
CTIS2024-516300-41-00 · EU Clinical Trials Information System · Recruiting
Key facts
| Trial ID | CTIS2024-516300-41-00 |
|---|---|
| Public title | A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexame-thasone induction therapy with either intravenous or subcutaneous isatuximab in patients with newly diagnosed multiple myeloma |
| Scientific title | A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexamethasone induction therapy with either intravenous or subcutaneous isatuximab in transplant-eligible patients with newly diagnosed multiple myeloma (GMMG HD8/ DSMM XIX) - GMMG-HD8/DSMM XIX |
| Primary sponsor | Universitaetsklinikum Heidelberg AöR |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | Austria;Germany |
| Conditions | Multiple Myeloma MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104;Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15];Therapeutic area: Diseases [C] - Neoplasms [C04] |
| Interventions | Product Name: Isatuximab, Product Code:PRD10653334, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: Lenalidomid HEXAL 5 mg Hartkapseln, Product Code:PRD7252103, Pharmaceutical Form: CAPSULE… |
| Registration date | Jul 10, 2024 |
| Target size | 514 |
| Secondary IDs | NCT06216158;2022-000996-38 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: