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Recurrent Plasma Cell MyelomaPhase 2NCT01085214

AZD6244 (Selumetinib) in Treating Patients With Multiple Myeloma

A Phase 2 study testing Laboratory Biomarker Analysis and Selumetinib in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by National Cancer Institute (NCI) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis and Selumetinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
9 sitesUnited States
Study dates
Mar 2010to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Mark O Hatfield-Warren Grant Magnuson Clinical Center

    Bethesda, Maryland, 20892

  • National Institutes of Health

    Bethesda, Maryland, 20892

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 2 Study of AZD6244 in Multiple Myeloma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the response rate of AZD6244 (selumetinib) hydrogen sulfate capsules in patients with relapsed or refractory multiple myeloma (MM).

SECONDARY OBJECTIVES:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Selumetinib
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • SelumetinibDrug

    Also called ARRY-142886, AZD6244, MEK Inhibitor AZD6244

    AZD6244 (Selumetinib), 75 mg was administered orally, twice a day, continuously for 28-day cycles

Study groups in NCT01085214
Study groupRoleWhat they receive
AZD6244 (Selumetinib) TreatmentExperimentalParticipants 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.
Receives: Other: Laboratory Biomarker Analysis; Drug: Selumetinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Duration of Response

    Mean duration of response in months. Estimated using the method of Kaplan-Meier.

    Measured: From response to disease progression or death, assessed up to 2 years

  2. Incidence of Toxicity That May Be Treatment Emergent

    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).

    Measured: 1 year, 11 months

  3. Progression Free Survival (PFS)

    Median PFS in months. Progressive Disease (PD): Increase of >= 25% from baseline. Estimated using the method of Kaplan-Meier.

    Measured: From registration to progression or death, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01085214
Sponsor's protocol ID
NCI-2012-02929
Other IDs
NCI-2012-02929, CDR669144, NCI-8631, 10-C-0079, 8631, N01CM00071, N01CM00100, N01CM62208
Status last verified
May 2015
First submitted
10 Mar 2010
Last updated
19 Aug 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis and Selumetinib in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by National Cancer Institute (NCI) at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01085214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.

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