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Trial record 1 of 1 for:    NCT 03030261
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Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03030261
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
Celgene
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT.

Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.


Condition or disease Intervention/treatment Phase
Multiple Myeloma in Relapse Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Procedure: Autologous stem cell transplant Drug: Melphalan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : February 28, 2026


Arm Intervention/treatment
Experimental: Elotuzumab + Pomalidomide + Dexamethasone + ASCT
  • (4) 28-day cycles of Elo-Pom-Dex induction:

    • Elotuzumab on Days 1, 8, 15, and 22 for Cycles 1-2 and on Days 1 and 15 for Cycles 3-4
    • Pomalidomide daily on Days 1-21 of all cycles
    • Dexamethasone on Days 1, 8, 15, and 22 of all cycles
  • Following Elo-Pom-Dex induction, patients will undergo standard of care ASCT melphalan conditioning. Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.
  • Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:

    • Elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+
    • Pomalidomide daily on Days 1-21 of all cycles
    • Dexamethasone on Days 1 and 15 of all cycles
  • Continuation therapy may continue until relapse or progression.
Drug: Elotuzumab

During induction therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1, 8, 15, and 22 for Cycles 1-2 and Days 1 and 15 for Cycles 3-4. Elotuzumab will be administered intravenously at a dose of 10 mg/kg.

During continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg.

Other Name: Empliciti

Drug: Pomalidomide
During induction therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 4 mg. During continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated.
Other Name: Pomalyst

Drug: Dexamethasone
During induction, dexamethasone will be taken by mouth on Days 1, 8, and 15 of each of four 28-day cycles at a starting dose of 40 mg. During continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time.
Other Name: Decadron

Procedure: Autologous stem cell transplant
-Standard of care
Other Name: ASCT

Drug: Melphalan
-Standard of care




Primary Outcome Measures :
  1. Event-free survival (EFS) rate [ Time Frame: 1 year ]
    -Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 1 year ]
    -Overall response rate (ORR) will be defined as the proportion of patients meeting the criteria for partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR).

  2. Complete response rate (CRR) [ Time Frame: 1 year ]
    • Complete response rate (CRR) will be defined as the proportion of patients meeting the criteria complete (CR) or stringent complete response (sCR)
    • Stringent complete response (sCR) requires all of the following:

      • CR as defined below
      • Normal free light chain ratio (0.26-1.65)
      • Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
    • Complete response (CR) requires all of the following:

      • Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine
      • If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65)
      • <5% plasma cells in the bone marrow
      • Disappearance of soft tissue plasmacytoma
    • Patients who do not meet the definition of CR based solely on residual monoclonal protein on serum electrophoresis and/or immunofixation, but are MRD-negative as described above, will also be considered CR.

  3. Minimal residual disease negative (MRD-negative) rate [ Time Frame: 1 year ]
    -Minimal residual disease (MRD) testing should be performed using clonoSEQ next-generation sequencing technology [22]. Patients will be classified as MRD-negative or MRD-positive based on the current detection limits of the test (1 MM cell per 1x10^6 cells).

  4. Event-free survival (EFS) [ Time Frame: Up to 5 years ]
    -Event-free survival (EFS) will be defined as time from ASCT to disease progression, relapse, or death, whichever occurs first. Patients who are removed from study therapy prior to any of these events occurring will be censored at the time of initiation of subsequent anti-myeloma treatment.

  5. Progression-free survival (PFS) [ Time Frame: Up to 5 years post completion of treatment ]
    -Progression-free survival (PFS) will be defined as time from ASCT to disease progression or relapse. Any patient who expires or withdraws prior to disease progression or relapse will be censored at last follow-up. Patients who are removed from study therapy prior to progression or relapse will be censored at the time of initiation of subsequent anti-myeloma treatment.

  6. Overall survival (OS) [ Time Frame: Up to 5 years post completion of treatment ]
    -Overall survival (OS) will be defined as time from ASCT to death due to any causes. Patients who are alive at the time of data analyses will be censored on the last known alive date. Patients who are removed from study therapy prior death will be censored at the time of initiation of subsequent anti-myeloma treatment.

  7. Toxicity of regimen as measured by frequency of adverse events per the number of participants treated [ Time Frame: Up to 30 days following completion of treatment (estimated to be 106 weeks) ]
    -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Refractory to or intolerant of lenalidomide maintenance following first autologous stem cell transplantation. Refractory is defined as disease relapse/progression on therapy or within 60 days of completing therapy. Intolerance is defined as the inability to administer ≥ 10 mg per day due to toxicity.
  • All US study participants must be registered into the mandatory POMALYST 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 2x106/kg CD34+ autologous stem cells available for transplantation.
  • At least 18 and no more than 75 years of age at enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Normal bone marrow and organ function as defined as ALL of the following:

    • 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)
    • AST(SGOT)/ALT(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.
  • Received systemic multiple myeloma therapy post-relapse/progression. Patients that received 1-2 cycles of salvage therapy, local radiation, and/or corticosteroids post-relapse/progression are eligible if there was no further disease progression following administration.
  • 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 (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
  • History of plasma cell leukemia or MM central nervous system (CNS) involvement.
  • Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
  • Diagnosed with another concurrent malignancy requiring treatment.
  • Known HIV or active hepatitis A, B, or C. Antidoby 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030261


Contacts
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Contact: Ravi Vij, M.D. (314) 454-8323 rvij@wustl.edu

Locations
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United States, Colorado
Colorado Blood Cancer Institute Not yet recruiting
Denver, Colorado, United States, 80218
Contact: Jeffrey V Matous, M.D.    720-754-4800      
Principal Investigator: Jeffrey V Matous, M.D.         
Sub-Investigator: Scott I Bearman, M.D.         
Sub-Investigator: Alireza Eghtedar, M.D.         
Sub-Investigator: Tara K Gregory, M.D.         
Sub-Investigator: Michael B Maris, M.D.         
Sub-Investigator: Peter A McSweeney, M.D.         
Sub-Investigator: Richard Nash, M.D.         
Sub-Investigator: Marcello Rotta, M.D.         
Sub-Investigator: Michael T Tees, M.D.         
Sub-Investigator: Henning H Schade, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ravi Vij, M.D.    314-454-8323    rvij@wustl.edu   
Principal Investigator: Ravi Vij, M.D.         
Canada, Ontario
University Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Christine Chen, M.D.    416-946-2827    Christine.Chen@uhn.ca   
Principal Investigator: Christine Chen, M.D.         
Sub-Investigator: Vishal Kukreti, M.D.         
Sub-Investigator: Suzanne Trudel, M.D.         
Sub-Investigator: Rodger Tiedemann, M.D.         
Sub-Investigator: Anca Prica, M.D.         
Sub-Investigator: Donna Reece, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Bristol-Myers Squibb
Celgene
Investigators
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Principal Investigator: Ravi Vij, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03030261     History of Changes
Other Study ID Numbers: 201701084
CA204-225 ( Other Identifier: Bristol-Myers Squibb )
PO-CL-MM-PI-008341 ( Other Identifier: Celgene )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Melphalan
Pomalidomide
Elotuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists