Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma

November 7, 2019 updated by: Celgene

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Thalidomide Following Multiple Oral Dosing in Subjects With Multiple Myeloma

Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, PK study in multiple myeloma subjects who are currently receiving thalidomide-containing therapy or are newly diagnosed. The study will consist of a screening phase, a baseline phase, a PK phase with a 5-day period of thalidomide treatment (200 mg/day), and an end-of-study evaluation on Day 6. Subjects will have frequent blood samples drawn for PK assessments on Days 5 and 6 in an inpatient setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest Cedex, France, 29609
        • Hopital Augustin Morvan
      • Grenoble Cedex 09, France, 38043
        • CHU Grenoble
      • Lille, France, 59037
        • CHRU-Hopital Claude Huriez
      • Tours cedex, France, 37044
        • CHRU Hôpital Bretonneau
      • Vandoeuvre Cedex, France, 54511
        • CHRU Hopital Brabois
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females ≥ at 18 the time of signing the informed consent document.
  • Documented diagnosis of multiple myeloma and receiving thalidomide containing therapy or initiating thalidomide-containing therapy.
  • Subjects must agree to temporally discontinue all antimyeloma therapies other than the study drug (thalidomide) at least 7 days prior to the PK phase (Day 1) and through post study procedures on Day 6.
  • All Females of Child Bearing Potential (FCBP) and male subjects must be counseled about pregnancy precautions and risks of fetal exposure.

  • Females of childbearing potential (FCBP) must:

    1. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact.
    2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
  • All other females must had either a hysterectomy or bilateral oophorectomy at least 6 months before screening (proper documentation required) OR been naturally postmenopausal for at least 24 consecutive months (i.e. who has not had menses at any time in the preceding 24 consecutive months). For this study, in subjects who are postmenopausal, estradiol level must be <30 pg/mL and plasma FSH must be >40 IU/L at screening.

  • Males (including those who have had a vasectomy):

    1. Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
    2. Must agree to not donate semen and sperm during study drug therapy and for 4 weeks after end of study drug therapy.
  • All subjects must also be counseled against sharing thalidomide and donating blood during and within 4 weeks of discontinuing thalidomide therapy

Exclusion Criteria:

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study (according to the Thalidomide product/prescribing information).
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study (according to the Thalidomide product information).
  • Any condition that confounds the ability to interpret data from the study (includes conditions that may affect the absorption of thalidomide, such as gastric bypass surgery, colon resection, etc.).
  • Pregnant or lactating females.
  • Any surgical or medical conditions that might significantly alter the absorption of study drug, such as gastrectomy, gastroenterostomy, bowel resection, pancreatic injury, or pancreatitis. (Cholecystecomy and appendectomy are permissible.)
  • Use of antimyeloma agents (other than thalidomide) or investigational agents within 7 days before the start of the PK phase.
  • Prior history of allergic reactions to thalidomide, thalidomide excipients (as referenced in the IB), or to related drugs (ie, lenalidomide).

  • Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years (from the time of signing the ICD). Exceptions include the following:

    1. Basal cell carcinoma of the skin
    2. Squamous cell carcinoma of the skin
    3. Carcinoma in situ of the cervix
    4. Carcinoma in situ of the breast
    5. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
  • Known human immunodeficiency virus (HIV) or infectious hepatitis (type A, B, or C) positivity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thalidomide Celgene™ 200mg once daily
5-day period of thalidomide treatment
Drug: Thalidomide Celgene™
200mg once daily and by mouth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters for plasma thalidomide: Tmax Cmax AUC t1/2 CL/F V/F
Time Frame: predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose
PK blood sampling for a single day (on Day 5)
predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-2001-CP-001
  • 2012-005529-62 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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