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

This is an interventional treatment trial for Relapsed Hematologic Malignancy focused on measuring hematopoietic stem cell transplant, lenalidomide, DLI Read More

Inclusion Criteria:

1. Age 18-65 years
2. Myeloma patients in first relapse after a sibling or unrelated allogeneic stem cell transplantation
3. Patients with measurable disease at time of relapse based on the IMWG criteria
4. All study participants must comply with the Revlimid Pregnancy Prevention Plan.

5. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Pregnancy Prevention Plan.

   Exclusion Criteria:

6. Relapse occurred within 180 days post allograft
7. Refractory to Len at any given time before allogeneic transplantation
8. Presence of ≥ grade II or uncontrolled acute GVHD
9. Presence of severe or uncontrolled chronic GVHD
10. Karnofsky score < 70%
11. 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
12. Known hypersensitivity to Len or Dex
13. 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)
14. 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)
15. 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
16. 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
17. Women who are lactating
18. 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
19. Participation in a trial with an investigational agent within 30 days prior to entry in the study
20. 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
21. Estimated probability to survive less than 6 months after initiation of Len and Dex
22. Current history of drug and/or alcohol abuse
23. Any abnormal condition or laboratory result that is considered by investigators capable of altering patient's condition, compliance or study outcome
24. Any patient who, in the opinion of investigators, should not participate in this study
25. Having received allogeneic stem cell transplantation in relapse after autologous transplant.
26. Having received Len therapy after allogeneic transplant, before relapse
27. 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