Status:
COMPLETED
Sequential Trial on Reduced Intensity Conditioning (RIC) Allogeneic Transplantation
Lead Sponsor:
European Myeloma Network B.V.
Conditions:
Hematologic Malignancies
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the current study is to improve the outcome of patients with hematologic malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II trial) by 2 interventions: r...
Eligibility Criteria
Inclusion
- Phase I: For the first 10 patients:
- Patients with any haematological malignancy in \> CR1 (first complete remission)
- Suitable related donor human leukocyte antigen (HLA)identical
- Age \> 18 and \< 70 years
- For the 10 subsequent patients:
- Patients with any haematological malignancy candidates to receive an allogeneic transplant
- Suitable related or unrelated donor (a maximum of 1 mismatched is allowed)
- Age \> 18 and \< 70 years phase II trial:
- High-risk multiple myeloma patients at first relapse / second complete remission candidates to receive an allogeneic transplantation
- Age:\> 18 \< 70 years.
- Suitable donor, related or unrelated (a maximum of 1 mismatched is allowed)
- Measurable disease
- High risk first relapse is defined as:
- First early relapse after Autologous Stem Cell Transplant (ASCT)\< 24 months
- First late relapses in case the patient does not achieve CR after second ASCT
- First relapse in patients with poor cytogenetic features
- All subjects must be able to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan.
Exclusion
- Any of the following:
- Prior severe comorbidity such as:
- Heart failure or previous infarction
- Uncontrolled Hypertension
- Arrhythmia
- Cirrhosis
- Peripheral neuropathy \>Grade 2, 14 days prior to inclusion
- Psychiatric disease
- Prior history of other neoplasia except for carcinoma in situ in the last 10 years
- Hypersensitivity to Bz, Boric acid mannitol.
- Patients unable to use appropriate contraceptive methods
- Patients who have received an investigational drug 30 days prior to inclusion
- Positive human immunodeficiency virus (HIV) or active viral hepatitis
- Patients with pericardial disease
- Patients with acute diffuse infiltrative pulmonary disease
- Patients not willing to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan
- Patients not willing to receive thromboprophylaxis during the consolidation phase will not be eligible.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01460420
Start Date
November 1 2011
End Date
June 29 2017
Last Update
July 6 2017
Active Locations (10)
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1
Medizinische Klinik and Poliklinik II, University Hospital
Würzburg, Germany
2
S Giovanni Battista Hospital
Torino, Italy
3
Azienda Ospedaliera Universitaria di Udine
Udine, Italy
4
Hospital Clinic i Provincial,
Barcelona, Spain