The feasibility study of elotuzumab/lenalidomide maintenance therapy in patients with multiple myeloma after autologous stem cell transplantation: a phase 2 study (EL-M study)
Chiba MM_EL_M study (Chiba MM_EL_M study)
Sakaida Emiko
Department of Hematology, Chiba University Hospital
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
+81-43-222-717
esakaida@faculty.chiba-u.jp
Sakaida Emiko
Department of Hematology, Chiba University Hospital
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
+81-43-222-7171
esakaida@faculty.chiba-u.jp
Not Recruiting
May. 20, 2019
Dec. 10, 2019
20
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
1. Patients must have undergone ASCT within 18 months of initiation of induction therapy for NDMM, and had not progressed in the interval between first-line ASCT.
2. Time to initiation of maintenance therapy. Patients may start maintenance therapy as early as 60 days post-transplant and up to 210 days post-transplant; as long as they meet the following criteria: platelet count >/=70,000/mm^3; neutrophil count >/=1000/mm^3; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=3 x ULN; creatinine < 2.0 mg/dl; ECG: neither ischemic change nor arrhythmia requiring medical intervention, cardiac ejection fraction: at least 50%; Recovered (i.e., </= Grade 1 toxicity) from the reversible effects of ASCT.
3. Male or female patients 20 years or older.
4. Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2, or 3 due to osteolytic lesions alone.
5. Female patients who: are postmenopausal for at least 24 months before the screening visit, OR; Are surgically sterile, OR; If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, 28 days prior to starting study drug, during study treatment and for 28 days after the last dose of study treatment, OR agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (i.e., status post vasectomy), who: Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR; Agree to completely abstain from heterosexual intercourse.
6. Written informed consent by patient including contraception.
1. Major surgery within 14 days before the first dose of study drug.
2. Radiotherapy within 14 days before enrollment.
3. Known active central nervous system involvement.
4. Progressive disease and/or leukemic status
5. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or GI procedure that could interfere with the oral absorption or tolerance of treatment.
6. History of hypersensitivity to mannitol or boron.
7. Female subject is pregnant or lactating.
8. Known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis.
9. Infection requiring systemic IV antibiotic therapy within 7 days before Cycle 1 Day 1 of therapy.
10. Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
11. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
12. Patients with a history of active malignancy during the past 5 years.
13. Patients with psychiatric disorders such as schizophrenia etc.
14. Failure to have fully recovered (i.e., </= Grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment.
15. Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
20age old over
No limit
Both
Multiple myeloma after autologous stem cell transplantation
Maintenance therapy
Multiple myeloma after autologous stem cell transplantation
Maintenance therapy post ASCT, Elotuzumab, Lenalidomide, MRD
D016896
The rate of VGPR+CR+sCR at one year after starting the maintenance therapy
1) 2-year progression-free survival
2) 2-year overall survival
3) 2-year time to progression
4) Molecular complete response rates after autologous stem cell transplantation, consolidation, and maintenance therapy
5) Detection of minimal residual disease after autologous stem cell transplantation, consolidation, and maintenance therapy
6) Analysis of immunological status after autologous stem cell transplantation, consolidation and maintenance therapy
7) The rate of non-hematological adverse events
8) The incidence of SPM
9) Vital sign
10) Laboratory data
Bristol-Myers Squibb Company
Not applicable
Chiba University Certified Clinical Research Review Board
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, Chiba
