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)
1 other identifier
interventional
146
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedJune 28, 2012
June 1, 2012
June 16, 2009
June 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
9 months from start of treatment
Secondary Outcomes (2)
Progression-free survival (PFS)
9 months from start of treatment
Incidence and relationship of severe adverse events
1 year from start of treatment
Study Arms (2)
Allogeneic stem cell transplant
EXPERIMENTALSecond scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine
High-dose melphalan chemotherapy
ACTIVE COMPARATORSecond high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
Interventions
Transplantation of stem cells from a MRD or MUD, respectively after dose-reduced conditioning versus autologous stem cell graft after preparation with melphalan 200 mg/m²
After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuerzburg University Hospitallead
- ClinAssess GmbHcollaborator
- Celgene Corporationcollaborator
- Amgencollaborator
- medac GmbHcollaborator
Study Sites (12)
Charité University Hospital - Virchow Klinikum
Berlin, Germany
Dresden University Hospital
Dresden, 01307, Germany
Erlangen University Hospital
Erlangen, 91054, Germany
Freiburg University Hospital
Freiburg im Breisgau, 79106, Germany
Jena University Hospital
Jena, Germany
Kiel University Hospital
Kiel, 24105, Germany
Munich Grosshadern University Hospital
Munich, 81377, Germany
University Hospital of Munich Technical University
Munich, 81675, Germany
Klinikum Nuremberg
Nuremberg, 90419, Germany
Regensburg University Hospital
Regensburg, 93053, Germany
Rostock University Hospital
Rostock, 18057, Germany
Ulm University Hospital
Ulm, 89081, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralf C Bargou, MD
Wuerzburg University Hospital, Dept. of Internal Medicine II
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 22, 2009
Study Start
June 1, 2009
Last Updated
June 28, 2012
Record last verified: 2012-06