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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
allogeneic stem cell transplant versus second autologous transplantation
RAD
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Allogeneic stem cell transplantation, Lenalidomide, IMiD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité University Hospital - Virchow Klinikum
  • Dresden University Hospital
  • Erlangen University Hospital
  • Freiburg University Hospital
  • Jena University Hospital
  • Kiel University Hospital
  • Munich Grosshadern University Hospital
  • University Hospital of Munich Technical University
  • Klinikum Nuremberg
  • Regensburg University Hospital
  • Rostock University Hospital
  • Ulm University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Allogeneic stem cell transplant

High-dose melphalan chemotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Response rate to RAD induction and transplant (stringent CR, CR, very good PR)

Secondary Outcome Measures

Progression-free survival (PFS)
Incidence and relationship of severe adverse events

Full Information

First Posted
June 16, 2009
Last Updated
June 27, 2012
Sponsor
Wuerzburg University Hospital
Collaborators
ClinAssess GmbH, Celgene Corporation, Amgen, medac GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00925821
Brief Title
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
ClinAssess GmbH, Celgene Corporation, Amgen, medac GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Allogeneic stem cell transplantation, Lenalidomide, IMiD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic stem cell transplant
Arm Type
Experimental
Arm Description
Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine
Arm Title
High-dose melphalan chemotherapy
Arm Type
Active Comparator
Arm Description
Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
Intervention Type
Procedure
Intervention Name(s)
allogeneic stem cell transplant versus second autologous transplantation
Intervention Description
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
Drug
Intervention Name(s)
RAD
Intervention Description
After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone.
Primary Outcome Measure Information:
Title
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
Time Frame
9 months from start of treatment
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
9 months from start of treatment
Title
Incidence and relationship of severe adverse events
Time Frame
1 year from start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf C Bargou, MD
Organizational Affiliation
Wuerzburg University Hospital, Dept. of Internal Medicine II
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Hospital - Virchow Klinikum
City
Berlin
Country
Germany
Facility Name
Dresden University Hospital
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Erlangen University Hospital
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Freiburg University Hospital
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Jena University Hospital
City
Jena
Country
Germany
Facility Name
Kiel University Hospital
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Munich Grosshadern University Hospital
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
University Hospital of Munich Technical University
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Nuremberg
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Regensburg University Hospital
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Rostock University Hospital
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Ulm University Hospital
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.lymphome.de/Gruppen/MMSG/index.jsp
Description
Website of the German Lymphoma Competence Net

Learn more about this trial

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

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