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Multiple MyelomaPhase 2NCT01698801

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

A Phase 2 study testing Lenalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene at 24 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 determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated 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
26 participants
Where
24 sitesJapan
Study dates
1 Oct 2012to 26 Jun 2018
Phase
Phase 2
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

  • Age ≥ 20 years at the time of signing the informed consent document
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
  • Able to adhere to the study visit schedule and other protocol requirements
  • Previously untreated, symptomatic multiple myeloma
  • Have measurable disease by protein electrophoresis analyses
  • At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan

Who cannot join

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  • Any condition that confounds the ability to interpret data from the study
  • Previous treatment with anti-myeloma therapy
  • Pregnant or lactating females
  • Any of the following laboratory abnormalities:
Show all 18Show fewer
  • Absolute neutrophil count (ANC) < 1,000/microL (1.0 × 10^9/L )
  • Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) < 50,000 cells/microL (50 × 10^9/L)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 × upper limit of normal
  • Renal failure requiring hemodialysis or peritoneal dialysis
  • Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
  • Subjects who are unable or unwilling to undergo antithrombotic therapy.
  • Peripheral neuropathy of ≥ grade 2 severity.
  • Uncontrolled systemic fungal, bacterial, or viral infection
  • Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
  • Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
  • Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
  • Ineligible for dexamethasone or dexamethasone is contraindicated.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • Hitachi General Hospital

    Hitachi, Ibaraki, 317-0077

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Kagoshima Medical Center

    Kagoshima, 892-0853

  • Kameda Medical Center

    Kamogawa, Chiba, 296-8602

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Iwate Medical University

    Morioka, Iwate, 020-8505

  • Nagoya Daini Red Cross Hospital

    Nagoya, Aichi-ken, 466-8650

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Japanese Red Cross Narita Hospital

    Narita, Chiba, 286-8523

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama Medical Center

    Okayama, 701-1192

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • Kinki University Hospital, Faculty of Medicine

    Sayama, Osaka, 589-8511

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Nishigunma National Hospital

    Shibukawa, Gunma, 377-8511

  • Shizuoka Cancer Center

    Sunto, Shizuoka, 411-8777

  • National Disaster Medical Center

    Tachikawa, Tokyo, 190-0014

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Tokyo, 135-8550

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935

  • Keio University Hospital

    Tokyo, 160-8582

  • Ehime University Hospital

    Touon, Ehime, 791-0295

Other trials in Japan

About this study

Official title: A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma

To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

Keywords
Lenalidomide, dexamethasone, newly diagnosed 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 Revlimid

    25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle

  • dexamethasoneDrug

    Also called LenaDex

    40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

Study groups in NCT01698801
Study groupRoleWhat they receive
Lenalidomide plus dexamethasoneExperimentalLenalidomide plus low-dose dexamethasone
Receives: Drug: Lenalidomide; Drug: dexamethasone

What is being measured

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

  1. Overall Response Rate

    Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.

    CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

    Measured: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.

Secondary outcomes (5)

  1. Time to Response

    Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).

    CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.

    Measured: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.

  2. Duration of Response

    Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.

    Measured: From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.

  3. Progression Free Survival (PFS)

    PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.

    Measured: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.

  4. Overall Survival (OS)

    The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

    Measured: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months

  5. Number of Participants With Adverse Events

    An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

    Measured: From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks

Timeline

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

  1. First posted3 Oct 2012 (estimated)
  2. Study start1 Oct 2012
  3. Primary completion26 Nov 2013
  4. Study completion26 Jun 2018

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01698801
Sponsor's protocol ID
CC-5013-MM-025
Status last verified
Oct 2018
First submitted
1 Oct 2012
Last updated
8 Nov 2018
Data monitoring committee
Yes

Publications

  • Suzuki K, Shinagawa A, Uchida T, Taniwaki M, Hirata H, Ishizawa K, Matsue K, Ogawa Y, Shimizu T, Otsuka M, Matsumoto M, Iida S, Terui Y, Matsumura I, Ikeda T, Takezako N, Ogaki Y, Midorikawa S, Houck V, Ervin-Haynes A, Chou T. Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study. Cancer Sci. 2016 May;107(5):653-8. doi: 10.1111/cas.12916. Epub 2016 Mar 30.

    PubMed 26914369

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and dexamethasone in people with Multiple Myeloma, run by Celgene at 24 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 8 inclusion and 18 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Dec 2014). 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?

Overall Response Rate (time frame: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 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 NCT01698801, 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 8 Nov 2018.

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