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

NCT ID: NCT00925821

Last Updated: 2012-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic stem cell transplant

Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine

Group Type: EXPERIMENTAL

allogeneic stem cell transplant versus second autologous transplantation

Intervention Type: PROCEDURE

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

RAD

Intervention Type: DRUG

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

High-dose melphalan chemotherapy

Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells

Group Type: ACTIVE_COMPARATOR

allogeneic stem cell transplant versus second autologous transplantation

Intervention Type: PROCEDURE

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

RAD

Intervention Type: DRUG

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

Interventions

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

Intervention Type: PROCEDURE

RAD

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinAssess GmbH

INDUSTRY

Sponsor Role: collaborator

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

medac GmbH

INDUSTRY

Sponsor Role: collaborator

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf C Bargou, MD

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital, Dept. of Internal Medicine II

Locations

Charité University Hospital - Virchow Klinikum

Berlin, , Germany

Dresden University Hospital

Dresden, , Germany

Erlangen University Hospital

Erlangen, , Germany

Freiburg University Hospital

Freiburg im Breisgau, , 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, , Germany

Countries

Germany

Related Links

http://www.lymphome.de/Gruppen/MMSG/index.jsp

Website of the German Lymphoma Competence Net

Other Identifiers

DSMM XII

Identifier Type: -

Identifier Source: org_study_id