Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925821
• Other study ID #: DSMM XII
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2009
• Last updated: June 27, 2012
• Start date: June 2009

Study information

• Verified date: June 2012
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• allogeneic stem cell transplant versus second autologous transplantation
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

Drug:
• RAD
After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.

Locations

Country	Name	City	State
Germany	Charité University Hospital - Virchow Klinikum	Berlin
Germany	Dresden University Hospital	Dresden
Germany	Erlangen University Hospital	Erlangen
Germany	Freiburg University Hospital	Freiburg
Germany	Jena University Hospital	Jena
Germany	Kiel University Hospital	Kiel
Germany	Munich Grosshadern University Hospital	Munich
Germany	University Hospital of Munich Technical University	Munich
Germany	Klinikum Nuremberg	Nuremberg
Germany	Regensburg University Hospital	Regensburg
Germany	Rostock University Hospital	Rostock
Germany	Ulm University Hospital	Ulm

Sponsors (5)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Amgen, Celgene Corporation, ClinAssess GmbH, medac GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate to RAD induction and transplant (stringent CR, CR, very good PR)		9 months from start of treatment	No
Secondary	Progression-free survival (PFS)		9 months from start of treatment	No
Secondary	Incidence and relationship of severe adverse events		1 year from start of treatment	Yes

External Links

•   Site of the International Myeloma Foundation
•   Website of the German Lymphoma Competence Net