Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
This study has been completed.
Sponsor:
Wuerzburg University Hospital
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
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Melphalan
Dexamethasone acetate
Dexamethasone sodium phosphate
Melphalan hydrochloride
Doxorubicin
Doxorubicin hydrochloride
Lenalidomide
U.S. FDA Resources
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
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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Lenalidomide Doxorubicin Melphalan BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013