Clinical trial · Interventional
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)
- 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)
Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.
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 |
|---|---|---|---|
| allogeneic stem cell transplant versus second autologous transplantation | Procedure | — | UNRESOLVED |
| RAD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Allogeneic stem cell transplant
- description
- Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine
- interventionNames
- Procedure: allogeneic stem cell transplant versus second autologous transplantation
- Drug: RAD
- type
- ACTIVE_COMPARATOR
- label
- High-dose melphalan chemotherapy
- description
- Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
- interventionNames
- Procedure: allogeneic stem cell transplant versus second autologous transplantation
- Drug: RAD
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Newly diagnosed multiple myeloma * Maximum of one prior systemic therapy (2 cycles) * Presence of CRAB criteria * Measurable disease parameters * Left ventricular ejection fraction at least 55% * DLCO of at least 60% * Adequate bone marrow function * Use of adequate contraception for female subjects with childbearing potential and all male subjects * Eligible for autologous and allogeneic stem cell transplantation * Bone marrow baseline sample evaluable for interphase cytogenetics Exclusion Criteria: * Any serious medical conditions preventing the subject from written informed consent * Progressive disease (PD) to any initial treatment * Pregnant or lactating females * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data * Use of any other experimental drug or therapy within 28 days of baseline * Preexisting neuropathy of ≥ grade 2 severity * Known hypersensitivity to thalidomide * Any prior use of lenalidomide * Positive for HIV or infectious hepatitis, type A, B or C after serologic testing * Serum creatinine despite induction therapy ≥ 2.0 mg/dL
References
Publications (0)
Data not yet available