Clinical trial · Interventional
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma
- 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 purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Cyclophosphamide plus filgrastim
- interventionNames
- Drug: Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Filgrastim
- interventionNames
- Drug: Filgrastim
Primary outcomes (1)
- measure
- Immunophenotypic response
- timeFrame
- Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent * symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma * measurable disease * WHO perf status 0-3 * eligible for ASCT Exclusion Criteria: * previously treated * peripheral neuropathy gr \>/= 2 * significant hepatic dysfunction * severe cardiac dysfunction * severe renal failure if not in dialysis
References
Publications (0)
Data not yet available