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

NCT00925821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2012-06-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ClinAssess GmbH

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • medac GmbH

    collaborator INDUSTRY

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Ralf C Bargou, MD · Wuerzburg University Hospital, Dept. of Internal Medicine II

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00925821 on ClinicalTrials.gov