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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03218163
• Other study ID #: J1747
• Secondary ID: IRB00125692
• Status: Terminated
• Phase: Phase 2
• Start date: September 27, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: January 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 15, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

3. 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;

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. Eastern Cooperative Oncology Group (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 alanine aminotransferase (ALT) and aspartate transaminase (AST) < 5x upper limit of normal (ULN)

3. Forced expiratory volume at one second (FEV1) and forced vital capacity (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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• MEDI-551 Maintenance
Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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