Status:
COMPLETED
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Wuerzburg University Hospital
Collaborating Sponsors:
ClinAssess GmbH
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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. Aft...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00925821
Start Date
June 1 2009
Last Update
June 28 2012
Active Locations (12)
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1
Charité University Hospital - Virchow Klinikum
Berlin, Germany
2
Dresden University Hospital
Dresden, Germany, 01307
3
Erlangen University Hospital
Erlangen, Germany, 91054
4
Freiburg University Hospital
Freiburg im Breisgau, Germany, 79106