Phase II Study of the combination of Elotuzumab with Lenalidomide as Maintenance Therapy post Autologous Stem Cell Transplant in Patients with Multiple Myeloma
Sheeba K. Thomas
The goal of this clinical research study is to learn if the combination of elotuzumab and revlimid (also called lenalidomide) can help to prevent multiple myeloma (MM) from coming back after patients have had an autologous stem cell transplant (a transplant using your own stem cells). The safety of this drug combination will also be studied.
Disease Group: Myeloma
Treatment Agent: Elotuzumab,Lenalidomide
Treatment Location: Only at MDACC
Sponsor: Bristol-Myers Squibb
Primary Objectives: Establish activity of elotuzumab and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients. Progression free survival (PFS) Secondary Objectives: Progression free survival 2 Overall survival Determine incidence of secondary primary malignancy Evaluate the best response rate (sCR/VGPR/PR) based on IMWG criteria Evaluate time to progression Evaluate time to next therapy Evaluate the tolerability and toxicity Preform MDASI- Myeloma symptom evaluation
IRB Review and Approval Date: 04/14/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Patients must have undergone autologous stem cell transplantation,
within 18 months of initiation of induction therapy for newly diagnosed myeloma.
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 >/=100,000/mm^3; Neutrophil count >/=1000/mm^3 (No growth factors within 5 days); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=3 x ULN; Creatinine < 2.5 mg/dl; Recovered (i.e., </= Grade 1 toxicity) from the reversible effects of autologous stem cell transplant.
3) Patients whose primary therapy was changed due to suboptimal response or toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCT.
4) Male or female patients 18 years or older.
5) Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.
6) 6. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
7) Female patients who: are postmenopausal for at leat 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 abstrain from heterosexual intercourse.
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 involvment.
4) 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.
5) Female subject is pregnant or lactating.
6) Known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis.
7) Infection requiring systemic IV antibiotic therapy within 7 days before Cycle 1 Day 1 of therapy.
8) Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
9) Failure to have fully recovered (i.e., </= Grade 1 toxicity) from the effects of prior chemotherapy regardless of the interval since last treatment.
10) 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.
Information and next steps
Sheeba K. Thomas
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