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Multiple MyelomaPhase 1/2NCT02115035

A Single Agent Study to Evaluate the Overall Response Rate, Safety and Tolerability of Orally Administered Vemurafenib

A Phase 1/2 study testing Vermurafenib 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Withdrawn

Withdrawn.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 objective is to evaluate the overall response rate of Vermurafenib 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?
Vermurafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2014to Jul 2017
Phase
Phase 1/2
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 F1 testing
  • Have been diagnosed with multiple myeloma by having met all three of the following IMWG criteria:
  • Clonal bone marrow plasma cells >10%
  • Presence of serum and/or urinary M-protein
  • Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following:
  • Hypercalcemia: serum calcium >11.5 mg/100 mL
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  • Renal insufficiency: serum creatinine >2 mg/dL
  • 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
  • Bone lesions: lytic lesions, severe osteopenia, or pathologic fractures
  • Have measurable disease defined by the following:
  • Serum M-protein ≥1g/dL or urine M-protein ≥200 mg/24 hours by protein electrophoresis
  • 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
  • Patient must be at least 3 weeks beyond the last multiple myeloma therapy and any previous therapy related toxicities must be CTCAE (Version 3.0) ≤ Grade 2 (except alopecia)
  • Have an Zubrod Performance Status of 0 to 2 (Appendix D)
  • Have life expectancy of at least 3 months in the opinion of the enrolling investigator
  • Be ≥18 years of age and willing to provide written informed consent
  • For women and men 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 weeks after completing the study, this must include two forms of birth control, including surgical sterilization, a reliable barrier method with spermicide, birth control pills, or contraceptive hormone implants.
  • Women of childbearing potential must have a negative serum pregnancy test within 24 hours before the initiation of VMFB therapy.
  • Have an absolute neutrophil count >1,000/mm3
  • Unsupported platelet count >35,000/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
  • 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 non-secretory myeloma
  • Have evaluable disease only according to CRAB diagnostic criteria and International Staging System (ISS)
  • No previous history of NRAS/KRAS/BRAF inhibitor
  • Have an active infection or ,in the opinion of the enrolling investigator, have a 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 enrollment
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  • In the opinion of the enrolling investigator, be eligible to receive any other standard therapy available that is known to extend life expectancy
  • Be pregnant, nursing, unwilling or unable to utilize two forms of birth control, including surgical sterilization, a reliable barrier method with spermicide, birth control pills, or contraceptive hormone implants.
  • 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.
  • 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 as determined by the enrolling investigator
  • 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 enrollment and/or daily or weekly chemotherapy without the potential for delayed toxicity within 14 days prior to enrollment.
  • Current use of a prohibited medication (Appendix F).
  • 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 cardiovascular risk including any of the following:
  • Ejection fraction by ECHO or MUGA must be > 40% and must be performed within 60 days prior to enrollment, unless the patient has received chemotherapy within that period of time in which case the LVEF must be repeated
  • New York Heart Association (NYHA) Class III or Class IV heart failure
  • History or evidence of current clinically significant uncontrolled arrhythmias. NOTE: Exception: Subjects with controlled atrial fibrillation for >30 days prior to study enrollment
  • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to study enrollment
  • 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;
  • Patients with intra-cardiac defibrillators;
  • 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 Single Agent Study to Evaluate the Overall Response Rate, Safety and Tolerability of Orally Administered Vemurafenib (VMRB) in Patients With Relapsed or Refractory Multiple Myeloma Who Have Activated BRAF Mutation

The objective is to evaluate the overall response rate of Vermurafenib when administered orally to patients with relapsed or refractory multiple myeloma.

Read the detailed description

This is an open-label study to evaluate the objective response rates of orally administered Vermurafenib for patients with double refractory multiple myeloma. Double refractory multiple myeloma is myeloma that has become refractory to two chemotherapeutic agents such as bortexomib and lenalidomide. The study will be conducted in two stages with an interim data analysis performed after enrollment of the initial 21 subjects to determine whether the study will enroll an additional 20 subjects.

Being tested
Vermurafenib
Keywords
Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • VermurafenibDrug

    Also called RO5185426, PLX4032

    960 mg of Vermurafenib twice daily orally on a 28 day schedule

Study groups in NCT02115035
Study groupRoleWhat they receive
VermurafenibExperimentalVermurafenib dosing will be given twice daily by oral administration in cycles of 28 days
Receives: Drug: Vermurafenib

What is being measured

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

  1. Changes in serum values

    To determine the changes in serum values of monoclonal protein

    Measured: 3 year

Timeline

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

  1. First posted15 Apr 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Why it stopped: Funding issues

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 1/2
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
NCT02115035
Sponsor's protocol ID
2014-07
Status last verified
Aug 2014
First submitted
9 Apr 2014
Last updated
27 Aug 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vermurafenib 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 26 inclusion and 25 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 27 Aug 2014. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Changes in serum values (time frame: 3 year). 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 NCT02115035.

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 27 Aug 2014.

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Clinical Trial NCT02115035 | AzTrials