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Trial record 2 of 10 for:    MEDI551

MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03218163
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Determine the progression free survival of high-risk or relapsed MM patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: MEDI-551 Maintenance Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Patients With Newly Diagnosed Poor-risk or Relapsed Multiple Myeloma
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MEDI-551 Treatment Arm
Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 GVHD, documentation of disease progression, or patient withdrawal for other reasons.
Drug: MEDI-551 Maintenance
Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV


Outcome Measures

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5 years ]
    The progression free survival (PFS) of high-risk or relapsed MM patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previous diagnosis of MM based on standard criteria as defined in Appendix A (Diagnostic Criteria for MM). Diagnostic studies need not be performed within 30 days of registration;
  2. Patients must meet one of the disease criteria outlined in either a, b, or c:

    a. Patients with newly diagnosed high-risk MM achieving a partial response (PR) or better at the time of enrollment in response to systemic anti-myeloma therapy, which may include autologous hematopoietic stem cell transplant (HSCT).

    High risk is defined by the presence of any one of the following:

    i. High-risk chromosomal translocations by FISH: t(4;14), t(14;16), t(14;20), del(17p), del(1p), amplification 1q ii. MyPRS GEP-70 high-risk signature either at diagnosis or at time of registration for the study iii. LDH > 300 U/L at diagnosis iv. Plasma cell leukemia v. Relapse from prior therapy within 12 months

    b. Patients with high-risk MM with at least 1 prior progression in PR or better in response to salvage systemic anti-myeloma therapy at the time of enrollment

    c. Patients with standard risk MM with 1 prior progression within 18 months from an autologous HSCT and in VGPR or better in response to salvage systemic anti-myeloma therapy at the time of enrollment.

  3. Patients must have a suitable first-degree or second-degree related, HLA-haploidentical or HLA-matched stem cell donor. The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype;
  4. No previous AlloSCT (syngeneic HSCT permissible);
  5. Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning;
  6. ECOG performance status of 0-2;
  7. Life expectancy > 6 months;
  8. Adequate end organ function as measured by:

    1. Left ventricular ejection fraction ≥ 35% or shortening fraction > 25%
    2. Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST < 5x ULN
    3. FEV1 and FVC > 40% of predicted
  9. Not pregnant or breast-feeding;
  10. No uncontrolled infection. Note: Infection is permitted if there is evidence of response to medication;
  11. The patient must be able to comprehend and have signed the informed consent.

Exclusion Criteria:

  1. Diagnosis of any of the following cancers:

    1. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
    2. Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)
    3. HTLV1 / HTLV2 positive
    4. Diagnosis of amyloidosis
  2. Failed to achieve at least a partial response (PR) to latest therapy;
  3. Known history of HIV infection;
  4. Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of registration;
  5. History of malignancy other than MM within 5 years of registration, except adequately treated basal or squamous cell skin cancer;
  6. History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration;
  7. Active hepatitis B as defined by seropositivity for hepatitis B surface antigen or patients with positive hepatitis B core antibody titers.
  8. Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis.
Contacts and Locations

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): NCT03218163


Contacts
Contact: William Matsui, MD 410-955-2808 matsuwi@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: William Matsui, MD    410-955-2808    matsuwi@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03218163     History of Changes
Other Study ID Numbers: J1747
IRB00125692 ( Other Identifier: JHMIRB )
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
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

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
bone marrow
bone marrow transplant
allogeneic
Medi-551

Additional relevant MeSH terms:
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