Multiple MyelomaPhase 1NCT00555100
Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
A Phase 1 study testing lenalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene at 5 sites in Japan.
Trial summary
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- lenalidomide and dexamethasone
- How many people
- 15 participants
- Where
- 5 sitesJapan
- Study dates
- 1 Jul 2007to 1 Dec 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with previously treated multiple myeloma
- Measurable levels of m-protein in serum >= 0.5 g/dL [5g/L]) or urine (>= 0.2 g excreted in a 24-hour collection sample)
- ECOG performance status of 0 - 2
- Willing to follow pregnancy precautions
Who cannot join
- Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years
- Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
- Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
- Patients with posterior subcapsular cataracts
- Patients with mental illness
- Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study
Show all 17Show fewer
- Pregnant or lactating females
- Grade 2 or worse neuropathy
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,000cells/mL Platelet count < 75,000/mL Serum creatinine > 2.5 mg/dL Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug
- Patients with scars from a recent viscus operation
- Patients with history of a desquamating (blistering) rash while taking thalidomide
- Patients with prior use of lenalidomide
- Patients with known HIV positivity.
- Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy.
- Patients with known history of hypersensitivity to dexamethasone.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Nagoya City University Hospital
Nagoya, Aichi-ken
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken
Niigata Cancer Center Hospital
Niigata
Jichi Medical University Hospital
Shimotsuke, Tochigi
Keio University Hospital
Tokyo
About this study
Official title: A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.
- Conditions
- Multiple Myeloma
- Being tested
- lenalidomide, dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
dexamethasoneDrug
40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Measured: first cycle (28 days)
Secondary outcomes (1)
Efficacy (M-protein)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study start1 Jul 2007
- Primary completion1 Dec 2010
- Study completion1 Dec 2010
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaaki Takatoku, M.D., Study director, Celgene K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555100
- Sponsor's protocol ID
- CC-5013-MM-017
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2007
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Iida S, Chou T, Okamoto S, Nagai H, Hatake K, Murakami H, Takagi T, Shimizu K, Lau H, Takeshita K, Takatoku M, Hotta T. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2010 Jul;92(1):118-26. doi: 10.1007/s12185-010-0624-7. Epub 2010 Jun 18.
PubMed 20559759
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 Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00555100
- Acronym / sponsor ID
- CC-5013-MM-017
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2007 (actual)
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Dec 2010 (actual)
- First posted
- 7 Nov 2007 (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.
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with previously treated multiple myeloma
- Measurable levels of m-protein in serum >= 0.5 g/dL [5g/L]) or urine (>= 0.2 g excreted in a 24-hour collection sample)
- ECOG performance status of 0 - 2
- Willing to follow pregnancy precautions
Key exclusion criteria (17 listed)
- Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years
- Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
- Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
- Patients with posterior subcapsular cataracts
- Patients with mental illness
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 |
|---|---|---|
| lenalidomide10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops. | Drug | – |
| dexamethasone40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops. | Drug | – |
Primary outcome
DLT
Time frame: first cycle (28 days)
1 secondary outcome
Efficacy (M-protein)
Time frame: 24 weeks
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 20559759Iida S, Chou T, Okamoto S, Nagai H, Hatake K, Murakami H, Takagi T, Shimizu K, Lau H, Takeshita K, Takatoku M, Hotta T. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2010 Jul;92(1):118-26. doi: 10.1007/s12185-010-0624-7. Epub 2010 Jun 18.
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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.
Masaaki Takatoku, M.D. study director
Celgene K.K.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene at 5 sites in Japan.
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 4 inclusion and 17 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 5 sites in Japan. 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?
DLT (time frame: first cycle (28 days)). 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 NCT00555100, 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.