AzTrials
AzTrials

Multiple MyelomaPhase 2NCT02348528

Open-label Extended Access Program on Lenalidomide Plus Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma Who Participated in CC-5013-MM021 for at Least 1 Year

A Phase 2 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 11 sites in China.

Completed

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

Official record
Search all trials

Trial summary

CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who participated in Study CC-5013-MM-021. 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?
Lenalidomide and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
11 sitesChina
Study dates
11 Sep 2012to 29 Sep 2016
Phase
Phase 2
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

  • Subjects who discontinued treatment but remained for long-term follow-up in the CC-5013-MM-021 study are required to sign an informed consent document (ICD) to roll over to the Safety Follow-up Phase of the Extended Access Program (EAP). These subjects do not require screening for eligibility but must agree to be followed for survival and Second Primary Malignancy (SPM) at a minimum of every 4 months (± 7 days) intervals for at least 5 years from the time the last on-study subject enrolled in Study CC-5013-MM-021.
  • Subjects who are consented for the Treatment Phase of the EAP must meet the following criteria to continue the same therapy as they received in the Study CC-5013-MM-021:
  • Completed at least 1year of lenalidomide plus low-dose dexamethasone (Rd) treatment and remained progression free under Rd treatment in Study CC-5013-MM-021 at the time of screening visit of this EAP.
  • Able to adhere study visit schedule, compliance with study drug and other protocol requirements in Study CC-5013-MM-024.
  • Consented to the EAP protocol.
  • Must agree to comply with all Pregnancy Prevention requirements.
Show all 14Show fewer
  • Females of childbearing potential (FCBP)1:
  • Must agree to use, and be able to comply with, at least 2 forms of reliable contraception simultaneously or to practice complete abstinence from heterosexual intercourse without interruption, from transferring/rolling over from the CC-5013-MM-021 study, at the screening visit for eligibility, throughout study drug therapy (including dose interruptions) and for 28 days after the end of study drug therapy, even if she has amenorrhea. This applies even if the subject practices complete and continued abstinence confirmed on a monthly basis.
  • Must agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 IU/mL (i.e., negative pregnancy test) at screening for eligibility and then every 28 days while on study. For any FCBP, pregnancy testing must continue at the same frequency as during the MM-021 study. If regular or no menstrual cycles, she must agree to ongoing pregnancy testing during the course of the study (every 28 days), during dose interruptions, at study discontinuation and 28 days following study drug discontinuation. If menstrual cycles are irregular, pregnancy testing must occur every 14 days while on study, at study discontinuation and at 14 and 28 days following study drug discontinuation. This requirement also applies to females of childbearing potential who practice complete and continued sexual abstinence.
  • Must agree not to breastfeed during study drug therapy and for at least 28 days following study drug discontinuation.
  • Male subjects:
  • Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and at least 28 days following study drug discontinuation.
  • Must agree to not donate semen or sperm during study drug therapy and for at least 28 days following study drug discontinuation.
  • Subjects who have a positive finding of pregnancy testing at screening will not be eligible for the Treatment Phase of the EAP but will be consented for the Safety Follow-up Phase in the EAP.

Who cannot join

  • Subjects will not continue treatment at the discretion of the physician if any of the following criteria occurred during treatment in the CC-5013-MM-021 study or during the Screening Phase.
  • All subjects that are not eligible to continue treatment will enter the Safety Follow-up Phase:
  • Serious hypersensitivity or anaphylaxis to lenalidomide or dexamethasone.
  • Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
  • Any other condition, including the presence of serious laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Previously discontinued lenalidomide treatment due to toxicity.
Show all 12Show fewer
  • Newly diagnosed malignancy other than Multiple Myeloma (MM), except 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 histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) or prostate cancer that is curative

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Peking University Third Hospital

    Beijing, 100081

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The 301 Hospital-Chinese PLA General Hospital

    Beijing, 300200

  • Xiangya Hospital of Central South University

    Changsha, 410008

  • Guangdong General Hospital

    Guangzhou, 510080

  • Nanfang Hospital of Southern medicine university in Guangzhou

    Guangzhou, 510515

  • 1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )

    Hangzhou, 310003

  • 1st Hospital Zhejiang University (The First Affiliated Hospital of Zhejiang University )

    Hangzhou, 310009

  • Shanghai Changzheng Hospital

    Shanghai, 200003

  • Shanghai 6th Hospital

    Shanghai, 200233

  • The 1st Hospital of Soochow University

    Suzhou, 215006

Other trials in China

About this study

Official title: A Multi-center, Open-label Extended Access Program of Lenalidomide Plus Low-dose Dexamethasone in Chinese Subjects With Relapsed/Refactory Multiple Myeloma Who Participated in Study CC-5013-MM-021 for at Least One Year.

CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide treatment for subjects who have shown therapeutic benefit.

Read the detailed description

After subjects who are still on treatment have completed at least 1 year of therapy in Study CC-5013-MM-021 (from the start date of lenalidomide treatment), the EAP will allow consented subjects who (1) have remained progression free under Rd treatment in Study CC-SO I3-MM-02 I to roll over to the Treatment Phase of the LAP to continue Rd treatment, and (2) have discontinued Rd therapy and are currently in the Long-Term Follow-up Phase in Study CC-5013-MM-021 to roll over to the Safety Follow-up Phase of the EAP for survival and SPM outcomes. The maximum duration of this LAP program is at least 5 years from the time the last on-study

Keywords
Multiple Myeloma, Relapsed, Refractory, Lenalidomide, Dexamethasone, open-label, CC-5013-MM-021
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02348528
Study groupRoleWhat they receive
Lenalidomide and dexamethasoneExperimentalCycle 1: 25 mg oral lenalidomide once daily on Days 1-21 every 28 Days and 40 mg oral dexamethasone on Days 8, 15, and 22. Cycle 2 and beyond: 25 oral lenalidomide once daily on Days 1-21 every 28 days and 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22. The starting doses of Rd regimen will be the same last doses that the subjects received in Study CC-5013-MM-021, unless event(s) that require dose adjustments (dose modifications, reductions and interruptions) per protocol occurred prior to roll-over.
Receives: Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

  1. Adverse Events (AEs)

    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A diagnosis or syndrome should be recorded on the AE page of the electronic case report form (eCRF) rather than the individual signs or symptoms of the diagnosis or syndrome. An overdose, accidental or intentional, whether or not it is associated with an AE, or abuse, withdrawal, sensitivity or toxicity to an investigational product should be reported as an AE. If an overdose is associated with an AE, the overdose and adverse event should be reported as separate terms.

    Measured: approximately 4 years

Secondary outcomes (3)

  1. Progression Free Survival (PFS

    Progression Free Survival is defined as the time between randomization and the first documented progressive disease or death, whichever occurred first

    Measured: approximately 4 years

  2. Time to Progression (TTP)

    Time to progression is defined as the time between randomization and disease progression as determined by the investigator

    Measured: approximately 4 years

  3. Overall Survival (OS)

    Overall Survival is defined as the time between randomization and death Safety Issue: No

    Click here to enter additional Secondary Outcome Measures following the format above.

    Measured: approximately 4 years

Timeline

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

  1. First posted28 Jan 2015 (estimated)
  2. Study start11 Sep 2012
  3. Primary completion29 Sep 2016
  4. Study completion29 Sep 2016

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02348528
Sponsor's protocol ID
CC-5013-MM-024
Status last verified
Nov 2019
First submitted
23 Jan 2015
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Du X, Jin J, Cai Z, Chen F, Zhou DB, Yu L, Ke X, Li X, Wu D, Meng F, DeMarco D, Zhang J, Mei J, Hou J. Long-term use of lenalidomide and low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: MM-024 Extended Access Program. BMC Cancer. 2016 Jan 28;16:46. doi: 10.1186/s12885-016-2069-8.

    PubMed 26821931

  • Soyer N, Patir P, Uysal A, Duran M, Unal HD, Durusoy R, Tombuloglu M, Sahin F, Tobu M, Vural F, Saydam G. Efficacy and safety of lenalidomide and dexamethasone in patients with relapsed/ refractory multiple myeloma: a real-life experience. Turk J Med Sci. 2018 Aug 16;48(4):777-785. doi: 10.3906/sag-1712-160.

    PubMed 30119153

  • Dinner S, Dunn TJ, Price E, Coutre SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.

    PubMed 29802551

  • 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

  • Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.

    PubMed 30204239

  • Cella D, McKendrick J, Kudlac A, Palumbo A, Oukessou A, Vij R, Zyczynski T, Davis C. Impact of elotuzumab treatment on pain and health-related quality of life in patients with relapsed or refractory multiple myeloma: results from the ELOQUENT-2 study. Ann Hematol. 2018 Dec;97(12):2455-2463. doi: 10.1007/s00277-018-3469-4. Epub 2018 Sep 4.

    PubMed 30178193

  • Wilke T, Mueller S, Bauer S, Pitura S, Probst L, Ratsch BA, Salwender H. Treatment of relapsed refractory multiple myeloma: which new PI-based combination treatments do patients prefer? Patient Prefer Adherence. 2018 Nov 9;12:2387-2396. doi: 10.2147/PPA.S183187. eCollection 2018.

    PubMed 30519004

  • Alahmadi M, Masih-Khan E, Atenafu EG, Chen C, Kukreti V, Tiedemann R, Trudel S, Reece DE. Addition of Cyclophosphamide "On Demand" to Lenalidomide and Corticosteroids in Patients With Relapsed/Refractory Multiple Myeloma-A Retrospective Review of a Single-center Experience. Clin Lymphoma Myeloma Leuk. 2019 Apr;19(4):e195-e203. doi: 10.1016/j.clml.2018.12.007. Epub 2018 Dec 20.

    PubMed 30723035

  • Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

    PubMed 30792190

  • Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

    PubMed 30773308

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 11 sites in China.

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 14 inclusion and 12 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 11 sites in China. 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?

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?

Adverse Events (AEs) (time frame: approximately 4 years). 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 NCT02348528, which also lists 10 linked publications.

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; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in