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

NCT03218163 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: J1747IRB00125692
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

bone marrow; bone marrow transplant; allogeneic; Medi-551

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The progression free survival (PFS) of high-risk or relapsed multiple myeloma (MM) patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.

  5 years

Study Arms (1)

MEDI-551 Treatment Arm

EXPERIMENTAL

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 graft-versus-host disease (GVHD), documentation of disease progression, or patient withdrawal for other reasons.

Drug: MEDI-551 Maintenance

Interventions

MEDI-551 Maintenance DRUG

Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV

MEDI-551 Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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 fluorescent in situ hybridization (FISH): t(4;14), t(14;16), t(14;20), del(17p), del(1p), amplification 1q ii. Myeloma Prognostic Risk Signature 70-Gene expression profiling (MyPRS GEP-70) high-risk signature either at diagnosis or at time of registration for the study iii. Lactate dehydrogenase (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 very good partial remission (VGPR) or better in response to salvage systemic anti-myeloma therapy at the time of enrollment.
• Patients must have a suitable first-degree or second-degree related, Human leukocyte antigen (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, major histocompatibility complex, class II, DR beta 1 (HLA-DRB1), and Major Histocompatibility Complex, Class II, DQ Beta 1 (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;
• No previous AlloSCT (syngeneic HSCT permissible);
• Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Life expectancy \> 6 months;
• Adequate end organ function as measured by:
• Left ventricular ejection fraction ≥ 35% or shortening fraction \> 25%
• Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and alanine aminotransferase (ALT) and aspartate transaminase (AST) \< 5x upper limit of normal (ULN)

You may not qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Philip Imus
• Organization: SKCCC

pimus1@jhmi.edu

4109558873

Study Officials

• Philip Imus, MD

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: September 27, 2017
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: January 14, 2019
• Results First Posted: May 29, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)