Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Center for International Blood and Marrow Transplant Research
With
National Marrow Donor Program
Celgene Corporation
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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®.
You may not be if
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.
Clareo Health | Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
