NCT01937442

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2015

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

September 4, 2013

Last Update Submit

November 7, 2019

Conditions

Multiple Myeloma

Keywords

Multiple myelomaPharmacokineticsThalidomide

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters for plasma thalidomide: Tmax Cmax AUC t1/2 CL/F V/F

    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

Study Arms (1)

Thalidomide Celgene™ 200mg once daily

EXPERIMENTAL

5-day period of thalidomide treatment

Drug: Thalidomide Celgene™

Interventions

Thalidomide Celgene™DRUG

200mg once daily and by mouth

Thalidomide Celgene™ 200mg once daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.
  • 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):
  • 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.
  • 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

You may not qualify if:

  • 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:
  • Basal cell carcinoma of the skin
  • Squamous cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hopital Augustin Morvan

Brest, 29609, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHRU-Hopital Claude Huriez

Lille, 59037, France

Location

CHRU Hopital Bretonneau

Tours, 37044, France

Location

CHRU Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Christie Hospital NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

  • Lund J, Gruber A, Lauri B, Duru AD, Blimark C, Swedin A, Hansson M, Forsberg K, Ahlberg L, Carlsson C, Waage A, Gimsing P, Vangsted AJ, Frolund U, Holmberg E, Gahrton G, Alici E, Hardling M, Mellqvist UH, Nahi H. Lenalidomide versus lenalidomide + dexamethasone prolonged treatment after second-line lenalidomide + dexamethasone induction in multiple myeloma. Cancer Med. 2018 Jun;7(6):2256-2268. doi: 10.1002/cam4.1422. Epub 2018 Apr 19.

    PMID: 29673108BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Robert Knight, MD

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 9, 2013

Study Start

November 7, 2013

Primary Completion

September 23, 2015

Study Completion

September 23, 2015

Last Updated

November 12, 2019

Record last verified: 2019-11

Locations

GB(2)FR(5)