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NCT03218163 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2019-01-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: MEDI-551 Maintenance
    label
    MEDI-551 Treatment Arm
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. MEDI-551 Treatment Arm
    description
    Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV
    name
    MEDI-551 Maintenance
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Progression Free Survival
    time Frame
    5 years
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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      true
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      occurrences
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        exact text
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        start
        0
      offset unit
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      query cond
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      query disease state id
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      source file
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      source json pointer
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    Preserved source evidence · Not medical advice