Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the past year. Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks. An autologous peripheral blood stem cell transplant is a procedure in which immature "stem cells" are collected and stored for future use. A high dose of chemotherapy is given to the patient to destroy myeloma cells, and the patient's stem cells are replaced. The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs to treat multiple myeloma.

Key facts

Study ID

NCT02655458

Run by

Hearn Jay Cho

People needed

15

Starts

2016-01-01

Expected to finish

2017-07-13

Last updated by the study team

2017-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• Subject has given 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
• Target Population
• Subjects with symptomatic MM by IMWG criteria who are receiving or have completed induction chemotherapy, who have achieved at least a PR on most recent therapy by IMWG criteria, and are eligible for auto-SCT for consolidation. A specific induction regimen is not dictated for this protocol, however, the induction regimen must not have contained melphalan (L-PAM, Alkeran).
• Age > 18 years or legal age of consent per local regulations.
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
• Documented evidence of newly diagnosed, symptomatic MM, by IMWG criteria within one year of enrollment
• Prior lenalidomide exposure is permitted only if the subject did not discontinue lenalidomide due to a related, grade ≥ 3 AE. Age and Reproductive Status
• Men and women of childbearing potential (WOCBP) must be using 2 reliable methods of contraception to avoid pregnancy throughout the study for a period of at least 30 days before and 90 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. See Section 4.3.3 for the definition of WOCBP and also refer to the Revlimid Risk Management Plan guidelines.
• WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). The first should be performed within 10 to 14 days and the second within 24 hours prior to the start of the study drug. A prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
• Women must not be breastfeeding.
• Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP, even if they have had a successful vasectomy, and must agree not to donate sperm during study drug therapy and for 90 days after therapy.
• Subjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapy.

You may not qualify if…

• Target Disease
• MGUS, Waldenström's macroglobulinemia, or asymptomatic (smoldering) myeloma.
• Active plasma cell leukemia (defined as either 20% of peripheral white blood cells comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L).
• Medical History and Concurrent Diseases
• All AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v.4.0) Grade ≤ 2.
• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• Acute renal failure due solely to readily reversible causes such as hypercalcemia, hyperuricemia, dehydration, hyperviscosity, or acute tubular necrosis from nephrotoxic drugs.
• Significant cardiac disease as determined by the investigator including:
• Known or suspected cardiac amyloidosis
• Congestive heart failure of Class III or IV of the NYHA classification
• Uncontrolled angina, hypertension or arrhythmia
• Myocardial infarction in the past 6 months
• Any uncontrolled or severe cardiovascular disease
• Prior cerebrovascular event with persistent neurologic deficit.
• Known HIV Infection or active hepatitis A, B or C.
• Any medical conditions that, in the investigator's opinion, would impose excessive risk to the subject.
• Examples of such conditions include:
• a. Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder b. Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent c. Active infection that requires parenteral anti-microbial or anti-parasitic treatment
• Prior or concurrent malignancy, except for the following:
• Adequately treated basal cell or squamous cell skin cancer;
• Or any other cancer from which the subject has been disease-free for > 5 years
• Uncontrolled diabetes (defined as Hgb A1C > 8.0%)
• Unable to tolerate thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or dose adjusted low-molecular weight heparin. Physical and Laboratory Test Findings
• Corrected serum calcium > 11.5 mg/dl within 2 weeks of enrollment.
• Absolute neutrophil count < 1000 cells/mm3. No granulocyte colony stimulating factors (G-CSF or GMCSF) allowed within 1 week of enrollment. No pegylated granulocyte colony stimulating factors are allowed within 3 weeks of treatment start.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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