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Multiple MyelomaPhase 2NCT02140840

UARK 2014-08 A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib

A Phase 2 study testing Trametinib in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the overall response rate of Trametinib when administered orally to patients with relapsed or refractory multiple myeloma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Trametinib
Type of treatment
Pill or oral medicine
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2015to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Been identified as having multiple myeloma with activating NRAS, KRAS or BRAF genetic mutations on CD138+ cells, identified by molecular genetic testing
  • Have been diagnosed with multiple myeloma by having met all three of the following IMWG criteria:
  • a Clonal bone marrow plasma cells >10% b Presence of serum and/or urinary M-protein (If no monoclonal protein is detected (non-secretory disease), then >/= 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.) c Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following: (i) Hypercalcemia: serum calcium >11.5 mg/100 mL (ii) Renal insufficiency: serum creatinine >2 mg/dL (iii) Anemia: normochromic, normocytic with a hemoglobin value >2 g/100 mL below the lower limit of normal or a hemoglobin value <10 g/100 mL (iv)Bone lesions: lytic lesions, severe osteopenia, or pathologic fracture.
  • Have measurable disease defined by the following:
  • Serum M-protein ≥1g/dL or urine M-protein ≥200 mg/24 hours by protein electrophoresis (ii) If neither serum nor urine M-protein meet the criteria above, then kappa or lambda serum FLC must be ≥10 mg/dL accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65) (Serum FLC should only be used for patients without measurable serum or urine M-protein spike.)
  • Have relapsed or refractory disease after two or more prior multiple myeloma treatment regimens, each of which may have consisted of either single or multiple therapies
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  • Be at least 3 weeks beyond the last multiple myeloma therapy and have recovered from acute toxicities of prior therapies measured by CTCAE Ver 3.0.
  • Have an Eastern Cooperative Oncology Group performance status of 0 to 2
  • Have life expectancy of at least 3 months
  • Be ≥18 years of age and willing to provide written informed consent
  • For women of childbearing potential, must have used effective contraceptive methods for previous 4 weeks and agree to continue using such methods during the study and for at least 4 months after completing the study, this must include the use of a male/female latex barrier method of contraception (for male participants (See APPENDIX K). TMTB is a pregnancy category D drug. A female of childbearing potential is defined as a female who has not been in natural menopause for the previous, consecutive 24 months, or undergone hysterectomy or bilateral oophortectomy. Women of childbearing potential must have a negative serum pregnancy test within 24 hours before the initiation of TMTB therapy.
  • Have an absolute neutrophil count >1,000/mm3
  • Have a platelet count >50,000/mm3
  • Have total direct bilirubin <2.0 mg/dL
  • Have aspartate aminotransferase and alanine aminotransferase ≤3 times the upper limit of normal
  • Have serum creatinine ≤2.5 times the upper limit of normal
  • Have hemoglobin ≥8.5 g/dL
  • All prior treatment- related toxicities must be CTCAE (Version 3.0) ≤ Grade 1 (except alopecia)
  • Subject is able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels

Who cannot join

  • Have an active infection or serious comorbid medical condition
  • Be receiving other concurrent anticancer agents or therapies
  • Be receiving other concurrent investigational therapies or have received investigational therapies within 3 weeks of screening, not inclusive of molecular genetic testing
  • Be eligible to receive any other standard therapy available that is known to extend life expectancy
  • For women be pregnant, nursing, unwilling or unable to utilize two forms of birth control, including the use of a latex condom.
  • Have a history of another malignancy, except as noted below Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer and/or subjects with indolent second malignancies are eligible.
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  • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
  • History of interstitial lung disease or pneumonitis.
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO).
  • Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to randomization and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to randomization.
  • History of retinal vein occlusion (RVO)
  • Symptomatic or untreated spinal cord compression.
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and HCV infection will be permitted).
  • History or evidence of cardiovascular risk including any of the following (See APPENDIX M for more details):
  • a LVEF<LLN b A QT interval of ≥ 480 msec corrected for heart rate using the Bazett's formula (QTcB;).
  • c History or evidence of current clinically significant uncontrolled arrhythmias.
  • Exception: Subjects with controlled atrial fibrillation for >30 days prior to study enrollment d History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to study enrollment
  • History or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA).
  • a Treatment refractory hypertension defined as a blood pressure of systolic> 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy; b Patients with intra-cardiac defibrillators; c Known cardiac metastases

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: A Phase II Open-Label, Multiple-Dose, Single Agent Study to Evaluate the Overall Response Rate of Orally Administered Trametinib in Patients With Relapsed of Refractory Multiple Myeloma

The purpose of this study is to evaluate the overall response rate of Trametinib when administered orally to patients with relapsed or refractory multiple myeloma

Read the detailed description

The effect of on tumor response will be determined using the International Myeloma Working Group uniform response criteria by analyzing changes in serum and urine values of monoclonal protein immunoglobulin kappa and lambda free light chain and ratio, microglobulin, lactate dehydrogenase, hemoglobin and C-reactive proten.

Being tested
Trametinib
Keywords
TMTB, Mekinist, Trametinib, relapse, refractory, response rate
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • TrametinibDrug

    Also called Mekinist, TMTB, JTP-74057, JTP-78296

    2 mg of Trametinib daily by mouth in 28 day cycles

What is being measured

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

  1. The response rate of Trametinib when administered orally to patients with relapsed multiple myeloma

    Measured: 28 day

Timeline

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

  1. First posted16 May 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionApr 2016 (estimated)
  4. Study completionApr 2016 (estimated)

Why it stopped: PI left institution

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02140840
Sponsor's protocol ID
202550
Status last verified
Apr 2016
First submitted
14 May 2014
Last updated
7 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trametinib in people with Multiple Myeloma, run by University of Arkansas at 1 site 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 19 inclusion and 19 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: withdrawn, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

The response rate of Trametinib when administered orally to patients with relapsed multiple myeloma (time frame: 28 day). 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 NCT02140840.

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 7 Apr 2016.

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