NCT01085214 · REGISTRY CONDITION SEARCH

AZD6244 (Selumetinib) in Treating Patients With 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: COMPLETED
Registry last update: 2015-08-19

This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.

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

Overall Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Incidence of Toxicity That May Be Treatment Emergent

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · NOT POSTED

Changes in Bone Marrow Microenvironment

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outcome · NOT POSTED

Level of Key Regulators

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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: * Confirmed diagnosis of multiple myeloma with relapsed or refractory disease following at least two prior therapies * Measurable disease defined as: * Serum monoclonal protein \>= 1 gm/dL or * Urine monoclonal protein of \>= 200 mg/24 hours, or * Measurable free light chains by free light chain assay of \>= 10 mg/dL with abnormal kappa to lambda free light chain ratio, or * Measurable bone disease, defined as \>= 1 unidimensionally measurable lesion (longest diameter to be recorded) \>= 20 mm with conventional techniques or \>= 10 mm with spiral computed tomography (CT) scan (for patients with lytic bone disease) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count: \>= 1,000/μL (independent of blood cell growth factors) * Platelets: \>= 75,000/μL (independent of blood cell growth factors or transfusion) * Total bilirubin: =\< 1.5 x upper normal limit; however, patients with documented Gilbert's syndrome are eligible * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]): \< 2.5 x upper limit of normal (ULN) * Creatinine: \< 3.0 x ULN * Known human immunodeficiency virus (HIV) infected patients meeting the following characteristics are eligible: * Cluster of differentiation (CD)4 cell count \>= 500/mm\^3 * Meeting either of the following: * Willing to suspend antiretroviral therapy for duration of protocol therapy or * On stable regimen of combination antiretroviral therapy that does not include either zidovudine or stavudine for at least 12 weeks and without evidence of toxicity * No HIV-associated condition that defines acquired immunodeficiency syndrome (AIDS) * Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met: * \>= 6 months have elapsed since allogeneic transplant * No graft vs. host disease (GVHD) is present * Not currently on immunosuppressive therapy * Women of child-bearing potential must agree to use a medically accepted form of contraception prior to, during, and for four weeks following study treatment; men must agree to use a medically accepted form of contraception prior to, during, and for sixteen weeks following study treatment * Able and willing to provide a written informed consent * Prior palliative and/or localized radiation therapy is permitted, provided at least 14 days have passed from date of last radiation therapy * Pulse oximetry of \>= 95% on room air Exclusion Criteria: * Any concurrent condition or planned treatment that would compromise study objectives or represent an unacceptable patient risk, including but not limited to: * Planned concurrent treatment for multiple myeloma other than bisphosphonates; ongoing corticosteroids for indications other than multiple myeloma allowed as long as the dose does not exceed 60 mg of prednisone per day or equivalent * Persisting effects of any previous or ongoing treatment that might compromise delivery of study treatment or assessment of adverse events * Planned concurrent treatment with any other investigational agents * Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration * No other malignancy unless the patient has been disease-free for \>= 1 year * Known multiple myeloma of central nervous system or leptomeninges * History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 * Previous mitogen activated protein kinase (MEK) inhibitor use * Uncontrolled hypertension, i.e., persistent blood pressure (BP) of \>= 160/95 * Significant cardiovascular disease (New York Heart Association class II, III or IV cardiac disease), hypertrophic cardiomegaly or restrictive cardiomyopathy, myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia unstable or a need for anti-arrhythmic therapy (use of medication for atrial fibrillation is allowed, if stable for at least 3 months) * Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing * Left ventricular ejection fraction (LVEF) =\< 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan * Any requirement for supplemental oxygen
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants receive AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Other: Laboratory Biomarker Analysis
Drug: Selumetinib
label
AZD6244 (Selumetinib) Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
AZD6244 (Selumetinib) Treatment
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
AZD6244 (Selumetinib) Treatment
description
AZD6244 (Selumetinib), 75 mg was administered orally, twice a day, continuously for 28-day cycles
name
Selumetinib
other Names
ARRY-142886
AZD6244
MEK Inhibitor AZD6244
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 37
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Effect of AZD6244 on the bone marrow microenvironment in MM.
measure
Changes in Bone Marrow Microenvironment
time Frame
Baseline to up to 20-30 hours after receiving the first dose of AZD6244
description
The level of key regulators of the MEK/MAPK and PI3K pathways and HSP90 and cell cycle regulators may determine the anti-tumor response to AZD6244 in vivo in multiple myeloma (MM).
measure
Level of Key Regulators
time Frame
Up to 20-30 hours after receiving the first dose of selumetinib

primary Outcomes

description
Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).
measure
Overall Response Rate
time Frame
Up to 2 years

secondary Outcomes

description
Mean duration of response in months. Estimated using the method of Kaplan-Meier.
measure
Duration of Response
time Frame
From response to disease progression or death, assessed up to 2 years
description
Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
measure
Incidence of Toxicity That May Be Treatment Emergent
time Frame
1 year, 11 months
description
Median PFS in months. Progressive Disease (PD): Increase of \>= 25% from baseline. Estimated using the method of Kaplan-Meier.
measure
Progression Free Survival (PFS)
time Frame
From registration to progression or death, assessed up to 2 years

Full study description

brief Summary: This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.
detailed Description: PRIMARY OBJECTIVES: I. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in patients with relapsed or refractory multiple myeloma (MM). SECONDARY OBJECTIVES: I. To evaluate the toxicity of AZD6244 in patients with MM. II. To estimate progression-free survival and duration of response to AZD6244. III. To test whether AZD6244 hydrogen sulfate capsules downregulate tumor cell phosphorylated mitogen-activated protein kinase (pERK)1/2. OUTLINE: Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 weeks.

Source references

Source notices and limitations

Discovery and provenance

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source file
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Preserved source evidence · Not medical advice