Clinical trial · Interventional
Lenalidomide, Bortezomib and Dexamethasone Induction Therapy With Either Intravenous or Subcutaneous Isatuximab in Patients With Newly Diagnosed Multiple Myeloma
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.
NCT05804032CI-TRIAL-00103594completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The trial aims to demonstrate the non-inferiority of subcutaneous to intravenous isatuximab administration in transplant-eligible patients with newly diagnosed multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Isatuximab | Drug | Isatuximab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A - Intravenous isatuximab
- description
- Patients in arm A are treated with 3 cycles RVd + i.v. isatuximab, followed by a standard intensification and autologous stem cell transplantation.
- interventionNames
- Drug: Isatuximab
- Drug: Lenalidomide
- Drug: Bortezomib
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Arm B - Subcutaneous isatuximab
- description
- Patients in arm B are treated with 3 cycles RVd + s.c. isatuximab, followed by a standard intensification and autologous stem cell transplantation.
- interventionNames
- Drug: Isatuximab
- Drug: Lenalidomide
- Drug: Bortezomib
- Drug: Dexamethasone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG) * Patient is eligible for high-dose melphalan (200 mg/m\^2 melphalan) and autologous stem cell transplantation * Measurable MM disease according to IMWG criteria, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements: serum M-protein ≥ 10 g/L; urine light-chain (M-protein) of ≥ 200 mg/24 hours; involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal * Age 18-70 years at trial inclusion Exclusion Criteria: * Patient has known hypersensitivity (or contraindication) to any of the components of study therapy * Systemic amyloid light-chain amyloidosis (except for localized AL amyloidosis limited to the skin or the bone marrow) * Plasma cell leukemia * Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression * Severe cardiac dysfunction (NYHA classification III-IV) * Patients with active or uncontrolled hepatitis B or C or detectable liver disease due to hepatitis B or C * HIV positivity * Patients with active, uncontrolled infections * Patients with severe renal insufficiency or requiring hemodialysis * Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events) * Patients with a history of any active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy * Platelet count \< 75 x 10\^9/L * Haemoglobin ≤ 8.0 g/dL, unless related to MM * Absolute neutrophil count (ANC) \< 1.0 x 10\^9/L (the use of colony stimulating factors within 14 days before the test is not allowed) * Corrected serum calcium \> 14 mg/dL (\> 3.5 mmol/L) * Pregnancy and lactation For further details on inclusion/exclusion criteria please refer to the study protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.