WHO ICTRP trial
Trial in patients with newly diagnosed myeloma to assess non-inferiority of…
EUCTR2022-000996-38-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2022-000996-38-DE |
|---|---|
| Public title | Trial in patients with newly diagnosed myeloma to assess non-inferiority of induction therapy with isatuximab/lenalidomide/ bortezomib/ dexamethasone when isatuximab is administered subcutaneously versus intravenously |
| 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 |
| Primary sponsor | Ruprecht-Karls-Universität Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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 | Newly diagnosed symptomatic multiple myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic… |
| Interventions | Product Name: Isatuximab Product Code: SAR650984 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Isatuximab Current Sponsor code: SAR650984 Concentration unit: mg/ml milligram(s)/millilitre Concentration… |
| Registration date | Oct 21, 2022 |
| Target size | 514 |
| Secondary IDs | GMMG-HD8/DSMM-XIX |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: