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Recurrent Plasma Cell MyelomaEarly Phase 1NCT02971410

Simvastatin in Overcoming Chemotherapy Resistance in Patients With Relapsed or Refractory Multiple Myeloma

A Early Phase 1 study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Simvastatin in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy resistance in patients with multiple myeloma that has come back or does not respond to treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Quality-of-Life Assessment and Simvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2017to Nov 2021
Phase
Early Phase 1
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

  • Patients must have a definitive diagnosis of multiple myeloma (using the International Myeloma Working Group Guidelines)
  • Patients must meet one of the following two requirements:
  • Have achieved minimal response (MR) or stable disease (SD) in current treatment regimen after receiving a minimum of two cycles
  • Have a partial response but show a decrease less than 25% or an increase less than 25% in measurable disease over a two month period
  • NOTE: Patients may be refractory to primary therapy or relapsed and have measurable or assessable disease; (refractory disease is defined as anything less than partial response [PR] or progression within 60 days of completing therapy)
  • Patients with multiple myeloma must have measurable disease; measurable disease may be paraprotein in serum or urine or the presence of free light chains in serum or urine defined by one or more of the following criteria:
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  • Presence of serum M-protein concentration > 1 g/dL
  • Urine M-protein excretion > 200 mg in 24-hour urine collection
  • Serum free light chain concentration >= 10 mg/dL and abnormal kappa/lambda ratio
  • Urine free light chain concentration >= 100 mg/L and abnormal kappa/lambda ratio
  • If female patient with reproductive capacity: on effective means of barrier birth control during the entire duration of the treatment
  • Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status of 0, 1, or 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 8 weeks
  • Absolute neutrophil count >= 500/ul
  • Platelets >= 30,000/ul
  • Total bilirubin < 2 times the upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3 x upper limit of normal
  • Patients must have adequate renal function as defined by a creatinine clearance >= 40 mL/min (measured or estimated by the Cockcroft-Gault formula)
  • Patients must have no signs of significant rhabdomyolysis determined by creatine phosphokinase (CPK) levels with a creatine kinase (CK) < 5 times the upper limit of normal
  • Patients must have recovered from acute toxicities resulting from therapy administered prior to entering this study to grade 1 or less (Common Terminology Criteria for Adverse Events [CTCAE] 4); alopecia may be unresolved
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Who cannot join

  • Patients who have not received any chemotherapy treatment for multiple myeloma prior to being enrolled in the study
  • Patients who have no measureable disease by serologic or urine markers (detectable disease only by bone marrow or imaging scans)
  • Patients who show progressive disease or are not tolerating the current chemotherapy regimen
  • Patients who were receiving simvastatin (dose > 40 mg/day) while receiving current chemotherapy regimen for multiple myeloma
  • Patients receiving any other investigational agent(s)
  • Active second malignancy in the last 3 years except for non-melanoma skin cancer or carcinoma-in-situ
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  • History of hypersensitivity reactions attributed to simvastatin
  • Patients receiving medications that may increase risk of rhabdomyolysis such as itraconazole, ketoconazole, erythromycin, cyclosporine, amiodarone, verapamil, clarithromycin, nefazodone, ranolazine, human immunodeficiency virus (HIV) protease inhibitors, gemfibrozil, posaconazole, danazol, amiodarone, diltiazem, and amlodipine
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myopathy, untreated hypothyroidism, hereditary myopathy in the family history, unstable angina pectoris, liver disease not due to multiple myeloma, cardiac arrhythmia that is symptomatic or not rate controlled, active connective tissue disease, active autoimmune disease, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are ineligible, as treatment involves unforeseeable risks to the embryo or fetus; female patients with reproductive capacity are required to use effective means of birth control during the entire duration of the treatment
  • Patients who have been on a statin other than simvastatin within 2 weeks of starting treatment on current study; these include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, and rosuvastatin; if patient is on statin, will need to stop treatment 2 weeks prior to starting treatment on study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Overcoming Chemotherapy Resistance in Refractory Multiple Myeloma With Simvastatin, A Pilot Study

This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy resistance in patients with multiple myeloma that has come back or does not respond to treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To examine the effect of simvastatin on myeloma (M)-protein and/or free light chains ratio when added to conventional chemotherapy for the treatment of multiple myeloma patients who have received up to 3 (=< 3) and > 3 different chemotherapy regimens. (group A and group B)

SECONDARY OBJECTIVES:

  1. To estimate the progression-free survival (PFS), time to progression (TTP), and duration of response (DOR) in group A, group B, and both groups combined.

II. To describe toxicities (frequency and severity during the treatment) in group A, group B, and both groups combined.

III. To estimate overall response (OR) in group A, group B, and both groups combined.

IV. To evaluate the quality of life (QoL) of patients on the combined treatment in group A, group B, and both groups combined.

OUTLINE:

Patients receive standard of care chemotherapy for up to 3 courses and simvastatin orally (PO) daily 2 days before the first dose of chemotherapy for up to 2 days after the last dose of chemotherapy. Treatment with simvastatin continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 3-5 weeks for the first 6 months, and every 1-3 months thereafter.

Being tested
Laboratory Biomarker Analysis, Quality-of-Life Assessment, Simvastatin
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

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • SimvastatinDrug

    Also called MK 733, Synvinolin, Zocor

    Given PO

Study groups in NCT02971410
Study groupRoleWhat they receive
Treatment (simvastatin)ExperimentalPatients receive standard of care chemotherapy for up to 3 courses and simvastatin (PO) daily 2 days before the first dose of chemotherapy for up to 2 days after the last dose of chemotherapy. Treatment with simvastatin continues in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Simvastatin

What is being measured

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

  1. Change in free light chain ratios

    The success rate will be estimated overall and within the strata groups and 95% confidence intervals will be calculated around the estimate. Will also estimate the change in free light chain ratios and provide confidence intervals for those estimates, both overall and within groups.

    Measured: Up to 126 Days

  2. Change in M-protein level measured using electrophoresis

    The success rate will be estimated overall and within the strata groups and 95% confidence intervals will be calculated around the estimate. Will also estimate the change in M-proteins and provide confidence intervals for those estimates, both overall and within groups.

    Measured: Up to 126 Days

Secondary outcomes (10)

  1. DOR

    Will estimate the mean duration of response and provide confidence intervals in the subset of patients who respond. The proportion (with confidence interval) of subjects achieving a clinical benefit response will be calculated.

    Measured: Up to 28 months

  2. Incidence of toxicities evaluated according to National Cancer Institute CTCAE version 4.0

    Toxicity data (both frequency and severity) will be summarized descriptively by showing the number of subjects experiencing each type of toxicity by grade for those with a grade 2 or higher.

    Measured: Up to 28 months

  3. OR including stringent complete remission (CR), CR, Partial Remission (PR), and very good PR

    The proportion (with confidence interval) of subjects achieving a clinical benefit response will be calculated.

    Measured: Up to 28 months

  4. Overall survival

    Will be analyzed initially using Kaplan-Meier estimation.

    Measured: Up to 28 months

  5. PFS

    Will be analyzed initially using Kaplan-Meier estimation.

    Measured: Up to 28 months

  6. QoL assessed using a survey designed by European Organization for Research and Treatment of Cancer (EORTC)

    Quality of life outcomes from the EORTC survey will be summarized descriptively.

    Measured: Up to 126 Days

  7. Response in patients who did and did not receive zoledronic acid with therapy

    Subset analysis will be done on patients who received zoledronic acid as part of their treatment while on study vs those who did not receive zoledronic acid to assess differences in response.

    Measured: Up to 28 months

  8. Time to first response

    Will be analyzed initially using Kaplan-Meier estimation.

    Measured: Up to 28 months

  9. Time to next therapy

    Will be analyzed initially using Kaplan-Meier estimation.

    Measured: Up to 28 months

  10. TTP

    Will be analyzed initially using Kaplan-Meier estimation.

    Measured: Up to 28 months

Timeline

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

  1. First posted23 Nov 2016 (estimated)
  2. Study startApr 2017 (estimated)
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2021 (estimated)

Why it stopped: PI no longer interested in pursuing study.

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
Early Phase 1
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
NCT02971410
Sponsor's protocol ID
IRB00040660
Other IDs
NCI-2016-01465, CCCWFU 26216, P30CA012197
Status last verified
Jun 2018
First submitted
4 Oct 2016
Last updated
2 Jul 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Simvastatin in people with Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma, run by Wake Forest University Health Sciences 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 21 inclusion and 11 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 2 Jul 2018. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Change in free light chain ratios (time frame: Up to 126 Days). The study lists 2 primary outcomes in all. 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 NCT02971410.

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 2 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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