About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

365607 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 03/08/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 03/08/2021.

Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

Clinicaltrials.gov identifier NCT03030261

Recruitment Status Recruiting

First Posted January 24, 2017

Last update posted January 22, 2021

Study Description

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:Multiple Myeloma in Relapse
  • Intervention/Treatment: Drug: Elotuzumab
    Drug: Pomalidomide
    Drug: Dexamethasone
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2017
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: February 2026
Arms and interventions
Arm Intervention/treatment
Experimental: Elotuzumab + Pomalidomide + Dexamethasone
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 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.

Drug: Pomalidomide
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.

Drug: Dexamethasone
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.
Outcome Measures
  • 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 evaluable 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 evaluable 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. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

- Failed 1 or 2 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 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

- 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:

- Refractory to elotuzumab and/or pomalidomide, defined as progressive disease or
clinical relapse on therapy or within 60 days following completion of therapy. Prior
exposure to elotuzumab and/or pomalidomide is allowed as long as patient is not
refractory to these agents.

- 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.

Contacts and Locations
Contacts

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

Locations

United States, Colorado
Colorado Blood Cancer Institute (Sarah Cannon)
Denver

United States, Georgia
Emory Winship Cancer Institute
Atlanta

United States, Missouri
Washington University School of Medicine
Saint Louis

Canada, Ontario
University Health Network - Princess Margaret Cancer Centre
Toronto

Sponsors and Collaborators

Washington University School of Medicine

Bristol-Myers Squibb

Celgene

Investigators

Principal Investigator: Ravi Vij, M.D. Washington University School of Medicine

More Information
  • Responsible Party: Washington University School of Medicine
  • ClinicalTrials.gov Identifier: NCT03030261 History of Changes
  • Other Study ID Numbers: 201701084, CA204-225, PO-CL-MM-PI-008341
  • First Posted: January 24, 2017 Key Record Dates
  • Last Update Posted: January 22, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell