Multiple MyelomaPhase 1NCT01937442
Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma
A Phase 1 study testing Thalidomide Celgene™ in people with Multiple Myeloma, run by Celgene at 7 sites in 2 countries.
Trial 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. 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?
- Thalidomide Celgene™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 7 Nov 2013to 23 Sep 2015
- Phase
- 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
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France5 sites
Hopital Augustin Morvan
Brest, 29609
CHU Grenoble
Grenoble, 38043
CHRU-Hopital Claude Huriez
Lille, 59037
CHRU Hopital Bretonneau
Tours, 37044
CHRU Hopital Brabois
Vandœuvre-lès-Nancy, 54511
United Kingdom2 sites
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Royal Marsden Hospital
Sutton, SM2 5PT
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide Celgene™
- Keywords
- Multiple myeloma, Pharmacokinetics, Thalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide Celgene™Drug
200mg once daily and by mouth
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide Celgene™ 200mg once daily | Experimental | 5-day period of thalidomide treatment Receives: Drug: Thalidomide Celgene™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters for plasma thalidomide: Tmax Cmax AUC t1/2 CL/F V/F
PK blood sampling for a single day (on Day 5)
Measured: predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study start7 Nov 2013
- Primary completion23 Sep 2015
- Study completion23 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Knight, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937442
- Sponsor's protocol ID
- CC-2001-CP-001
- Other IDs
- 2012-005529-62
- Status last verified
- Nov 2019
- First submitted
- 4 Sep 2013
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29673108
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Thalidomide Following Multiple Oral Dosing in Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01937442
- Acronym / sponsor ID
- CC-2001-CP-001
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Pharmacokinetics, Thalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2013 (actual)
- Primary completion
- 23 Sep 2015 (actual)
- Study completion
- 23 Sep 2015 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide Celgene™ 200mg once daily | Experimental | Drug: Thalidomide Celgene™5-day period of thalidomide treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide Celgene™200mg once daily and by mouth | Drug | Thalidomide Celgene™ 200mg once daily |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Background: PubMed 29673108Lund 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.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Knight, MD study director
Celgene Corporation
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thalidomide Celgene™ in people with Multiple Myeloma, run by Celgene at 7 sites in 2 countries.
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 12 inclusion and 14 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: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, United Kingdom. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT01937442, which also lists 1 linked publication.
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 12 Nov 2019.