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

June 27, 2012 updated by: Wuerzburg University Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité University Hospital - Virchow Klinikum
      • Dresden, Germany, 01307
        • Dresden University Hospital
      • Erlangen, Germany, 91054
        • Erlangen University Hospital
      • Freiburg, Germany, 79106
        • Freiburg University Hospital
      • Jena, Germany
        • Jena University Hospital
      • Kiel, Germany, 24105
        • Kiel University Hospital
      • Munich, Germany, 81377
        • Munich Grosshadern University Hospital
      • Munich, Germany, 81675
        • University Hospital of Munich Technical University
      • Nuremberg, Germany, 90419
        • Klinikum Nuremberg
      • Regensburg, Germany, 93053
        • Regensburg University Hospital
      • Rostock, Germany, 18057
        • Rostock University Hospital
      • Ulm, Germany, 89081
        • Ulm University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allogeneic stem cell transplant
Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine
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.
Active Comparator: High-dose melphalan chemotherapy
Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
Time Frame: 9 months from start of treatment
9 months from start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 9 months from start of treatment
9 months from start of treatment
Incidence and relationship of severe adverse events
Time Frame: 1 year from start of treatment
1 year from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

Celgene Corporation
Amgen
ClinAssess GmbH
medac GmbH

Investigators

  • Principal Investigator: Ralf C Bargou, MD, Wuerzburg University Hospital, Dept. of Internal Medicine II

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSMM XII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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