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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuerzburg University Hospital
• Collaborators: Amgen; Celgene Corporation; ClinAssess GmbH; medac GmbH
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Lenalidomide; Liposomal doxorubicin; Melphalan; Thalidomide

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