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

This study has been completed.
Sponsor:
Collaborators:
ClinAssess GmbH
Celgene Corporation
Amgen
medac GmbH
Information provided by (Responsible Party):
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT00925821
First received: June 16, 2009
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Procedure: allogeneic stem cell transplant versus second autologous transplantation
Drug: RAD
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Response rate to RAD induction and transplant (stringent CR, CR, very good PR) [ Time Frame: 9 months from start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 9 months from start of treatment ] [ Designated as safety issue: No ]
  • Incidence and relationship of severe adverse events [ Time Frame: 1 year from start of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 146
Study Start Date: June 2009
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925821

Locations
Germany
Charité University Hospital - Virchow Klinikum
Berlin, Germany
Dresden University Hospital
Dresden, Germany, 01307
Erlangen University Hospital
Erlangen, Germany, 91054
Freiburg University Hospital
Freiburg, Germany, 79106
Jena University Hospital
Jena, Germany
Kiel University Hospital
Kiel, Germany, 24105
Munich Grosshadern University Hospital
Munich, Germany, 81377
University Hospital of Munich Technical University
Munich, Germany, 81675
Klinikum Nuremberg
Nuremberg, Germany, 90419
Regensburg University Hospital
Regensburg, Germany, 93053
Rostock University Hospital
Rostock, Germany, 18057
Ulm University Hospital
Ulm, Germany, 89081
Sponsors and Collaborators
Wuerzburg University Hospital
ClinAssess GmbH
Celgene Corporation
Amgen
medac GmbH
Investigators
Principal Investigator: Ralf C Bargou, MD Wuerzburg University Hospital, Dept. of Internal Medicine II
  More Information

Additional Information:
No publications provided

Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT00925821     History of Changes
Other Study ID Numbers: DSMM XII
Study First Received: June 16, 2009
Last Updated: June 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wuerzburg University Hospital:
Allogeneic stem cell transplantation
Lenalidomide
IMiD

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Lenalidomide
Liposomal doxorubicin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 24, 2014