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Elotuzumab, Pomalidomide, and Dexamethasone in Treating Patients with Relapsed of Refractory Multiple Myeloma Undergoing Second Stem Cell Transplant

Trial Status: Active

This phase II trial studies how well elotuzumab, pomalidomide, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory) who are undergoing a second stem cell transplant. Elotuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pomalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as dexamethasone, lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Giving elotuzumab, pomalidomide, and dexamethasone may work better in treating patients with multiple myeloma.

Inclusion Criteria

  • Histologically confirmed diagnosis of multiple myeloma
  • Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression
  • Failed 1 or 2 prior lines of treatment for multiple myeloma; a line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression; once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun; local radiation or corticosteroids will not be considered treatment for multiple myeloma
  • Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
  • Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment)
  • All United States (US) study participants must be registered into the mandatory pomalidomide (POMALYST) Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the POMALYST REMS program; for Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
  • Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS program; for Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program
  • Candidate for second autologous stem cell transplantation per local institution’s guidelines with at least 2 x 10^6/kg CD34+ autologous stem cells available for transplantation
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count >= 1000/mm^3
  • Platelets >= 75,000/mm^3 (transfusions not permitted within 7 days of screening)
  • Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3.0 x IULN
  • Creatinine clearance >= 15 mL/min
  • Females of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through day +100 visit; should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately
  • Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

Exclusion Criteria

  • Prior exposure to elotuzumab or pomalidomide
  • More than one prior transplant prior to study entry with the exception of tandem transplantation; tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants
  • Presence of peripheral neuropathy >= grade 3 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v 4.0)
  • History of plasma cell leukemia or multiple myeloma (MM) central nervous system (CNS) involvement
  • Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis
  • Diagnosed with another concurrent malignancy requiring treatment
  • Known human immunodeficiency virus (HIV) or active hepatitis A, B, or C; antibody testing not required for screening
  • Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
  • Receiving any other investigational agents within 14 days prior to enrollment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Pregnant and/or breastfeeding; females of childbearing potential must have two negative pregnancy tests; the first test should be performed within 10-14 days of study entry, and the second test within 24 hours prior to prescribing pomalidomide

Colorado

Denver
Colorado Blood Cancer Institute
Status: ACTIVE
Contact: Jeffrey Victor Matous

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
Contact: Ravi Vij
Phone: 314-454-8323

Ontario

Toronto
University Health Network-Princess Margaret Hospital
Status: ACTIVE
Contact: Christine I. Chen

PRIMARY OBJECTIVE:

I. To evaluate the one-year event-free survival (EFS) rate of patients with relapsed/refractory multiple myeloma following second autologous stem cell transplantation (ASCT) with elotuzumab-pomalidomide-dexamethasone (Elo-Pom-Dex) continuation therapy.

SECONDARY OBJECTIVES:

I. To evaluate the overall response rate (ORR) of patients with relapsed/refractory multiple myeloma following second ASCT with Elo-Pom-Dex continuation therapy.

II. To evaluate the complete response rate (CRR) of patients with relapsed/refractory multiple myeloma following second ASCT with Elo-Pom-Dex continuation therapy.

III. To evaluate the minimal residual disease negative (MRD-negative) rate of patients with relapsed/refractory multiple myeloma following second ASCT with Elo-Pom-Dex continuation therapy.

IV. To evaluate the event-free survival (EFS) of patients with relapsed/refractory multiple myeloma following second ASCT with Elo-Pom-Dex continuation therapy.

V. To evaluate the progression-free survival (PFS) of patients with relapsed/refractory multiple myeloma following second ASCT with Elo-Pom-Dex continuation therapy.

VI. To evaluate the overall survival (OS) of patients with relapsed/refractory multiple myeloma following second ASCT with Elo-Pom-Dex continuation therapy.

VII. To evaluate the toxicity of second ASCT with Elo-Pom-Dex continuation therapy.

OUTLINE:

Within days 80 and 120 post-ASCT, patients receive dexamethasone intravenously (IV) or orally (PO) and elotuzumab IV on days 1 and 15 of cycles 1-6, and day 1 of subsequent cycles. Patients also receive pomalidomide PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually for up to 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Ravi Vij

  • Primary ID 201701084
  • Secondary IDs NCI-2017-00101
  • Clinicaltrials.gov ID NCT03030261