Clinical trial NCT00925821: Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Allogeneic stem cell transplantation
Lenalidomide
IMiD
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: ClinAssess GmbH
name: Celgene Corporation
name: Amgen
name: medac GmbH
First posted: 2009-06-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
timeFrame: 9 months from start of treatment
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 9 months from start of treatment
measure: Incidence and relationship of severe adverse events
timeFrame: 1 year from start of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital - Virchow Klinikum
city: Dresden
country: Germany
facility: Dresden University Hospital
city: Erlangen
country: Germany
facility: Erlangen University Hospital
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Jena
country: Germany
facility: Jena University Hospital
city: Kiel
country: Germany
facility: Kiel University Hospital
city: Munich
country: Germany
facility: Munich Grosshadern University Hospital
city: Munich
country: Germany
facility: University Hospital of Munich Technical University
city: Nuremberg
country: Germany
facility: Klinikum Nuremberg
city: Regensburg
country: Germany
facility: Regensburg University Hospital
city: Rostock
country: Germany
facility: Rostock University Hospital
city: Ulm
country: Germany
facility: Ulm University Hospital
Study officials:
affiliation: Wuerzburg University Hospital, Dept. of Internal Medicine II
name: Ralf C Bargou, MD
role: PRINCIPAL_INVESTIGATOR
References: