Status:
COMPLETED
Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Lead Sponsor:
Center for International Blood and Marrow Transplant Research
Collaborating Sponsors:
National Marrow Donor Program
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transp...
Eligibility Criteria
Inclusion
- One prior allograft from an 8/8 or 7/8 allele matched related or unrelated donor, received 60 to 90 days prior to initiation of lenalidomide
- Meet the diagnostic criteria of symptomatic myeloma at anytime prior to allogeneic HCT
- Have high-risk multiple myeloma
- Received ≤ three (3) prior lines of therapy. Prior therapies may include: combination chemotherapy, monotherapy, lenalidomide and autologous HCT. Localized radiation therapy does not count as a single line of therapy. Previous progression on lenalidomide does not exclude participation in the study.
- Received a reduced intensity conditioning regimen
- Received or are receiving a GVHD prophylaxis regimen of a calcineurin inhibitor in combination with either methotrexate, mycophenolate mofetil (MMF) or sirolimus
- Karnofsky performance score ≥ 80 or ECOG ≤ 2
- There must be at least 50% donor chimerism and no evidence of falling donor chimerism within 1 month of enrollment
- Laboratory test results within range, within 14 days prior to initiation of lenalidomide
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Exclusion
- Disease progression at time of study entry
- Patients with any grade III-IV GVHD at the time of study entry
- Patients requiring additional immunosuppressive therapy to control acute GVHD other than corticosteroids and immunosuppressive agents used for prophylaxis.
- Concomitant use of other investigational agents
- Patients who have received donor lymphocyte infusions
- Active CNS malignancy
- Uncontrolled bacterial, viral, or fungal infections
- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ \< 5 years from study entry.
- Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
- Known positive for HIV or active infectious hepatitis.
- Women who are pregnant or breastfeeding.
- New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00847639
Start Date
February 1 2009
End Date
March 1 2014
Last Update
April 4 2014
Active Locations (8)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
3
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601