Len/Dex/DLI in Relapsed Multiple Myeloma After Allogeneic Stem Cell Transplant

Prior treatment

• Refractory to Len at any given time before allogeneic transplantation
• Females of child-bearing potential not agreeing to remain abstinent or to use 2 simultaneous effective methods of contraception from at least 4 weeks before, to at least 4 weeks following discontinuation of Len. Males not agreeing to use a condom during any sexual contact with females of child-bearing potential from at least 4 weeks before, to at least 4 weeks following discontinuation of Len
• Participation in a trial with an investigational agent within 30 days prior to entry in the study
• Inability to provide written informed consent prior to initiation of any study-related procedures, or inability, in the opinion of investigators, to comply with all requirements of the study
• Having received allogeneic stem cell transplantation in relapse after autologous transplant.
• Having received Len therapy after allogeneic transplant, before relapse

Other illness

• Known hypersensitivity to Len or Dex
• Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or HCV-RNA positivity)
• Presence of another malignancy with an expected survival estimated \< 75% at 5 years (complete resection of basal cell carcinoma or squamous cell carcinoma, complete resection of a ductal carcinoma in situ, presence of lobular carcinoma in situ, complete resection of carcinoma in situ of the cervix, or an in situ or low-risk prostate cancer after curative therapy are not exclusion criteria)
• Current history of drug and/or alcohol abuse

Lab values

• Bilirubin \> 50 μmol/L unless felt to be related to Gilbert's disease or hemolysis; AST and ALT \> 5 x upper limit of normal (ULN); alkaline phosphatase \> 5 x ULN
• Any abnormal condition or laboratory result that is considered by investigators capable of altering patient's condition, compliance or study outcome
• Poor organ function defined as either: diffusing capacity of the lung for carbon monoxide corrected for hemoglobin using Dinakara method (DLCOc) \< 50%; forced expiratory volume in 1 second \< 50%; left ventricular ejection fraction (LVEF) \< 40% evaluated by echocardiogram or multi-gated acquisition scan (MUGA); uncontrolled arrhythmia; symptomatic cardiac disease; creatinine clearance \< 30 mL/minute; liver cirrhosis

Other

• Relapse occurred within 180 days post allograft
• Presence of ≥ grade II or uncontrolled acute GVHD
• Presence of severe or uncontrolled chronic GVHD
• Karnofsky score \< 70%
• Positive beta-human chorionic gonadotropin pregnancy test, to be performed in all women of childbearing potential at screening and baseline. Female study participants who are surgically sterile (hysterectomy) or who have been postmenopausal for at least 12 consecutive months are automatically eligible for this criterion
• Women who are lactating
• Female of child-bearing potential who are planning to become pregnant while enrolled in this study up to 4 weeks after the last Len dose
• Estimated probability to survive less than 6 months after initiation of Len and Dex
• Any patient who, in the opinion of investigators, should not participate in this study

• Age 18-65 years
• Myeloma patients in first relapse after a sibling or unrelated allogeneic stem cell transplantation
• Patients with measurable disease at time of relapse based on the IMWG criteria
• All study participants must comply with the Revlimid Pregnancy Prevention Plan.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Pregnancy Prevention Plan.