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Multiple MyelomaPhase 3NCT00928486

A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma

A Phase 3 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
8 sitesJapan
Study dates
28 Apr 2009to 10 Sep 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Must understand and voluntarily sign the informed consent form
  • Age ≥ 20 years at the time of signing the informed consent form
  • Subjects with previously treated multiple myeloma defined as follows:
  • Subjects must have received at least 1 prior anti-myeloma drug treatment regimen; and
  • Considered to have progression of disease (PD) that occurred either during or following the completion of the last anti-myeloma treatment regimen utilized prior to enrollment into this study
  • Measurable levels of M-protein in serum (greater than or equal to 0.5 g/dL [5g/L]) or urine (greater than or equal to 0.2 g excreted in a 24-hour collection sample)
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Females of childbearing potential (FCBP) must agree to use one or more of the following forms of contraception or abstain from heterosexual contact completely and have the male partners use a condom on the occasion of heterosexual contact in the following periods below:
  • For at least 28 days before starting study drug (in particular, the subject must abstain from heterosexual contact for 2 weeks prior to prescribing lenalidomide).
  • During the treatment phase (including the dose withholding period) For at least 28 days after the discontinuation/completion of the study drug (Methods of contraception)
  • Birth control pills
  • Intrauterine device (IUD)
  • Bilateral tubal ligation (FCBP must be referred to a health care provider who is familiar with contraceptive methods, if needed).
  • Male subject must agree to use a condom during sexual contact with female irrespective of pregnancy potential
  • Subjects must agree that study drug must be immediately discontinued, if pregnancy or a positive pregnancy test does occur in a female study subject or the partner of a male study subject during study participation

Who cannot join

  • Pregnant or lactating females
  • Subjects with a history of acute myocardial infarction within the past 6 months before starting the study drugs
  • Subjects with any history or concurrent conditions of deep vein thrombosis or pulmonary embolus within the past 3 years before starting study drugs
  • Subjects with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
  • Subjects with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
  • Subjects with posterior subcapsular cataracts
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  • Subjects with peripheral neuropathy of ≥Grade 2
  • Subjects with any history or concurrent conditions which the Principal Investigator / subinvestigators consider inappropriate for participation in this study, and subjects with a serious disease or a mental disease, which is considered to become more risky if the subjects participate in this study.
  • Subjects with a history of desquamative (blistering) rash while taking thalidomide
  • Subjects with a history of using lenalidomide
  • Subjects who have used thalidomide within 28 days before starting the study drugs
  • Subjects with a history of hypersensitivity to dexamethasone
  • Subjects who discontinued treatment due to grade 3 or 4 toxicity from high dose dexamethasone
  • Subjects with a surgical wound after a visceral surgery performed recently
  • Subjects who have undergone radiation therapy within 14 days before starting the study drugs
  • Subjects who have used a chemotherapeutic agent, an immunomodulating agent or a study drug (a drug not commercially available) intended for the treatment of multiple myeloma (MM) within 28 days before starting the study drug
  • Subjects with any history or concurrent conditions of malignancies, other than MM, unless the subject has been free of the disease for 3 years:
  • 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 histologic finding of prostate cancer Tumor, Lymph Nodes, Metastasis (TNM) stage of T1a or T1b)
  • Known human immunodeficiency virus (HIV) infection or HIV-1 positivity
  • Subjects who have been diagnosed as an hepatitis b virus (HBV) carrier
  • Subjects who are applicable to any of the following abnormal laboratory findings:
  • Absolute neutrophil count : < 1,000 /μL (1.0×10^9 /L)
  • Platelet count: <75,000 /μL (75×10^9 /L)
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT): > 3.0 times the upper limit of the standard range
  • Creatinine clearance: < 30 mL/min

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-5866

  • Osaka Red Cross Hospital

    Osaka, Osaka, 543-8555

  • Tokushima University

    Tokushima, Tokushima, 770-8503

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

About this study

Official title: A Safety Confirmation Study On Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma

To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma.

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

    Also called CC-5013, Revlimid

    Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle

  • DexamethasoneDrug

    Also called Decadron

    Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle

Study groups in NCT00928486
Study groupRoleWhat they receive
Lenalidomide and DexamethasoneExperimentalLenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
Receives: Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

  1. Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)

    A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)

    Measured: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks

Secondary outcomes (2)

  1. Myeloma Response Rate

    Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.

    Measured: From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks

  2. Kaplan-Meier Estimates of Duration of Response (DoR)

    Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia >11.5mg/dL

    Measured: From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks

Timeline

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

  1. First posted26 Jun 2009 (estimated)
  2. Study start28 Apr 2009
  3. Primary completion10 Sep 2010
  4. Study completion10 Sep 2010

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
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00928486
Sponsor's protocol ID
CC-5013-MM-022
Status last verified
Nov 2019
First submitted
9 Jun 2009
Last updated
20 Nov 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 8 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 16 inclusion and 29 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 20 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 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) (time frame: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks). 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 NCT00928486.

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 20 Nov 2019.

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