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

Phase 2

Active, not recruiting

• Conditions: Relapsed Hematologic Malignancy; Multiple Myeloma

• Registration Number: NCT03413800
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-1-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age 18-65 years<br><br> 2. Myeloma patients in first relapse after a sibling or unrelated allogeneic stem cell<br> transplantation<br><br> 3. Patients with measurable disease at time of relapse based on the IMWG criteria<br><br> 4. All study participants must comply with the Revlimid Pregnancy Prevention Plan.<br><br> 5. Females of reproductive potential must adhere to the scheduled pregnancy testing as<br> required in the Revlimid Pregnancy Prevention Plan.<br><br> Exclusion Criteria:<br><br> 6. Relapse occurred within 180 days post allograft<br><br> 7. Refractory to Len at any given time before allogeneic transplantation<br><br> 8. Presence of = grade II or uncontrolled acute GVHD<br><br> 9. Presence of severe or uncontrolled chronic GVHD<br><br> 10. Karnofsky score < 70%<br><br> 11. Bilirubin > 50 µmol/L unless felt to be related to Gilbert's disease or hemolysis;<br> AST and ALT > 5 x upper limit of normal (ULN); alkaline phosphatase > 5 x ULN<br><br> 12. Known hypersensitivity to Len or Dex<br><br> 13. Active infection with any of the following viruses: HIV, HTLV-1 or 2, hepatitis B<br> (defined as HBsAg positivity) or hepatitis C (defined as anti-HCV positivity or<br> HCV-RNA positivity)<br><br> 14. Presence of another malignancy with an expected survival estimated < 75% at 5 years<br> (complete resection of basal cell carcinoma or squamous cell carcinoma, complete<br> resection of a ductal carcinoma in situ, presence of lobular carcinoma in situ,<br> complete resection of carcinoma in situ of the cervix, or an in situ or low-risk<br> prostate cancer after curative therapy are not exclusion criteria)<br><br> 15. Positive beta-human chorionic gonadotropin pregnancy test, to be performed in all<br> women of childbearing potential at screening and baseline. Female study participants<br> who are surgically sterile (hysterectomy) or who have been postmenopausal for at<br> least 12 consecutive months are automatically eligible for this criterion<br><br> 16. Females of child-bearing potential not agreeing to remain abstinent or to use 2<br> simultaneous effective methods of contraception from at least 4 weeks before, to at<br> least 4 weeks following discontinuation of Len. Males not agreeing to use a condom<br> during any sexual contact with females of child-bearing potential from at least 4<br> weeks before, to at least 4 weeks following discontinuation of Len<br><br> 17. Women who are lactating<br><br> 18. Female of child-bearing potential who are planning to become pregnant while enrolled<br> in this study up to 4 weeks after the last Len dose<br><br> 19. Participation in a trial with an investigational agent within 30 days prior to entry<br> in the study<br><br> 20. Inability to provide written informed consent prior to initiation of any<br> study-related procedures, or inability, in the opinion of investigators, to comply<br> with all requirements of the study<br><br> 21. Estimated probability to survive less than 6 months after initiation of Len and Dex<br><br> 22. Current history of drug and/or alcohol abuse<br><br> 23. Any abnormal condition or laboratory result that is considered by investigators<br> capable of altering patient's condition, compliance or study outcome<br><br> 24. Any patient who, in the opinion of investigators, should not participate in this<br> study<br><br> 25. Having received allogeneic stem cell transplantation in relapse after autologous<br> transplant.<br><br> 26. Having received Len therapy after allogeneic transplant, before relapse<br><br> 27. Poor organ function defined as either: diffusing capacity of the lung for carbon<br> monoxide corrected for hemoglobin using Dinakara method (DLCOc) < 50%; forced<br> expiratory volume in 1 second < 50%; left ventricular ejection fraction (LVEF) < 40%<br> evaluated by echocardiogram or multi-gated acquisition scan (MUGA); uncontrolled<br> arrhythmia; symptomatic cardiac disease; creatinine clearance < 30 mL/minute; liver<br> cirrhosis

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Len-Dex-DLI in patients with relapsed myeloma measured by progression-free survival

Secondary Outcome Measures

Name	Time	Method
Incidence of grade =III non hematologic toxicity and incidence of grade =IV hematologic toxicity;Incidence of acute GVHD;Incidence of chronic GVHD;Maximum grades of acute and chronic GVHD;Response to treatment;Non-relapse mortality after DLIs;Overall survival at 2 years;Incidence of progression at 2 years;Disease status assessment by flow cytometry;Disease status assessment by PET scan;Evaluation of quality of life (QoL) during treatment;Evaluation of the BM microenvironment by transcriptome analysis before and after treatments