AzTrials
AzTrials

Multiple MyelomaPhase 2NCT01593410

Study of Lenalidomide and Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 13 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

The purpose of this study is to determine the efficacy of lenalidomide plus low-dose dexamethasone in Chinese subjects with relapsed or refractory multiple myeloma. Even though the efficacy and safety of lenalidomide has already been well-demonstrated in other populations including Asians, this study will assess the… 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
194 participants
Where
13 sitesChina
Study dates
1 Aug 2010to 3 Jan 2013
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

  • Understand and voluntarily sign informed consent form
  • Age ≥ 18 years at the time of signing consent
  • Prior or current diagnosis of Durie-Salmon Stage II or III multiple myeloma AND have disease progression after at least 2 cycles of systemic anti-myeloma treatment or have relapsed with progressive disease after treatment.
  • Measurable levels of myeloma paraprotein in serum (≥ 0.5 g/dL [5 g/L] or urine (≥ 0.2 g excreted in a 24-hour collection sample).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan requirements.

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subjects with non-secretory multiple myeloma by Serum Protein Electrophoresis (SPEP) and Urine Protein Electrophoresis (UPEP) assessment.
  • Pregnant or lactating females
  • Any of the following laboratory abnormalities:
  • Absolute neutrophil count of < 1000 cells/mm3 (1.0 X 109/L)
  • Platelet count < 50,000/mm3 (50 X 109/L) in subjects in whom < 50% of the bone marrow nucleated cells were plasma cells
Show all 26Show fewer
  • Renal failure requiring dialysis or peritoneal dialysis
  • Serum glutamic oxaloacetic transaminase, (SGOT)/ Aspartate-Aminotransferase (AST) > 3.0 x upper limit of normal (ULN)
  • Serum total bilirubin > 2.0 mg/dL (34μmol/L)
  • Any condition, including the presence of laboratory abnormalities, which placed subject at unacceptable risk if participating in the study or which would confound the ability to interpret study data.
  • Significant active cardiac disease within the previous 6 months.
  • Prior history of malignancies, other than multiple myeloma, unless the subject has been free of disease for ≥ 3 years. Exceptions include the following:
  • Basal cell carcinoma of the skin
  • Carcinoma in situ of the cervix
  • Carcinoma in situ of the breast
  • Squamous cell carcinoma of the skin
  • Incidental histologic finding of prostate cancer (Tumor, Node, and Metastasis [TNM] stage of T1a or T1b)
  • Known hypersensitivity to thalidomide or dexamethasone
  • Prior history of uncontrollable side effects to dexamethasone therapy
  • Peripheral neuropathy ≥ grade 2
  • Prior use of lenalidomide
  • Use of any standard/experimental anti-myeloma drug therapy within 28 days of the start of study drug or use of any experimental non-drug therapy (e.g. donor leukocyte/mononuclear cell infusion) within 56 days of the start of study drug)
  • Unable or unwilling to undergo antithrombotic therapy
  • History of deep vein thrombosis (DVT) or pulmonary emboli (PE) within the past 12 months
  • Known HIV positivity
  • Active infectious hepatitis A, B, or C or chronic carriers of hepatitis B with hepatitis B surface antigen (HBsAG) positive or if the hepatitis B viral deoxyribonucleic acid (HBV DNA) level is detectable by polymerase chain reaction (PCR).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • 307 Hospital of Chinese PLA

    Beijing, 100071

  • Peking University Third Hospital

    Beijing, 100081

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Chinese PLA General Hospital

    Beijing, 300200

  • Xiangya Hospital of Central- South University

    Changsha, 410008

  • Guangdong General Hospital

    Guangzhou, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515

  • The First Hospital Affiliated of College Medicine, Zhejiang University

    Hangzhou, 310003

  • The First Hospital Affiliated of College Medicine, Zhejiang University

    Hangzhou, 310009

  • Shanghai Changzheng Hospital

    Shanghai, 200003

  • Shanghai 6th People's Hospital

    Shanghai, 200233

  • Changhai Hospital

    Shanghai, 200433

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

Other trials in China

About this study

Official title: A Multi-center, Open-Label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to determine the efficacy of lenalidomide plus low-dose dexamethasone in Chinese subjects with relapsed or refractory multiple myeloma.

Even though the efficacy and safety of lenalidomide has already been well-demonstrated in other populations including Asians, this study will assess the efficacy and safety as well as pharmacokinetics of lenalidomide in Chinese subjects. In addition, this study will generate clinically meaningful information in guiding the therapeutic use of lenalidomide for Chinese subjects.

Read the detailed description

This is a Phase II, multicenter, single arm, open-label trial which will enroll Chinese subjects in China with relapsed/refractory multiple myeloma that will assess the efficacy and safety of lenalidomide plus low-dose dexamethasone regimen (Rd) given until progressive disease (PD) or discontinuation of lenalidomide for any reason.

There are two cohorts in this protocol, Pharmacokinetic Assessment Treatment Cohort and Treatment Cohort without Pharmacokinetic (PK) Assessment. The first 10 subjects who are ≤ 75 years old and have a baseline Creatinine Clearance ≥ 60 mL/min will participate in pharmacokinetic assessment during the first 8 days of Cycle 1. During this cohort, all subjects will receive 25mg oral lenalidomide once daily on days 1 -21 of each 28-day cycle. During the first cycle of this cohort, subjects will also receive 40mg oral dexamethasone daily on Days 8, 15, and 22 (and no dexamethasone on day 1). Beginning with Cycle 2, subjects will receive 25mg oral lenalidomide once daily on days 1 -21 of each 28-day cycle and 40mg oral dexamethasone daily on Days 1, 8, 15 and 22 of each 28-day cycle.

Once 10 subjects have been enrolled in the PK Assessment Treatment Cohort, the Treatment Cohort without PK Assessment will begin. During this cohort, subjects will receive lenalidomide 25 mg p.o. once daily on Days 1-21 and dexamethasone 40 mg p.o. once daily on Days 1, 8, 15, and 22 of each 28-day cycle. In both cohorts, subjects will continue Rd therapy until the documentation of PD or discontinuation of study therapy due to any reason including intolerable toxicity.

For the primary analysis, response will be assessed according to the European Group for Blood and Marrow Transplantation EBMT (Bladé) criteria by an Independent Response Adjudication Committee (IRAC). Response will also be assessed according to the International Myeloma Working Group (IMWG) criteria and used as an exploratory analysis.

Keywords
Efficacy/Safety, Lenalidomide and Low-Dose Dexamethasone, Chinese Subjects, Relapsed/Refractory 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 every 28 days

  • DexamethasoneDrug

    Cycle 1: 40 mg oral dexamethasone once daily on Days 8, 15, and 22. Cycle 2 and beyond: 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22

Study groups in NCT01593410
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.
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

    Complete Response (CR) or partial Response (PR) using the European Group for Blood and Marrow Transplantation (EBMT) (Bladé) criteria.

    Measured: Up to 24 months

Secondary outcomes (10)

  1. Adverse Events

    Number of participants with Adverse Events

    Measured: Up to 24 months

  2. Progression Free Survival (PFS)

    Number of participants who survive without progressing by the EBMT (Bladé) criteria

    Measured: Up to 24 months

  3. Overall Survival

    Number of participants alive

    Measured: Up to 24 months

  4. Response duration

    Length of time participants respond

    Measured: Up to 24 months

  5. Maximum observed concentration in plasma

    Pharmacokinetics - Cmax

    Measured: Days 1, 2, 7, 8, and 9 of Cycle 1

  6. Area under the plasma concentration-time curve

    Pharmacokinetics - AUC

    Measured: Days 1, 2, 7, 8, and 9 of Cycle 1

  7. Time to maximum concentration

    PK- Tmax

    Measured: Days 1, 2, 7, 8, and 9 of Cycle 1

  8. Terminal half-life

    Pharmacokinetics - T1/2

    Measured: Days 1, 2, 7, 8, and 9 of Cycle 1

  9. Apparent total body clearance

    Pharmacokinetics - CL/F

    Measured: Days 1, 2, 7, 8, and 9 of Cycle 1

  10. Apparent volume of distribution

    Pharmacokinetics - Vz/F

    Measured: Days 1, 2, 7, 8, and 9 of Cycle 1

Timeline

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

  1. First posted8 May 2012 (estimated)
  2. Study start1 Aug 2010
  3. Primary completion3 Jan 2013
  4. Study completion3 Jan 2013

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
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01593410
Sponsor's protocol ID
CC-5013-MM-021
Status last verified
Sep 2017
First submitted
4 May 2012
Last updated
20 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Hou J, Du X, Jin J, Cai Z, Chen F, Zhou DB, Yu L, Ke X, Li X, Wu D, Meng F, Ai H, Zhang J, Wortman-Vayn H, Chen N, Mei J, Wang J. A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial. J Hematol Oncol. 2013 Jun 19;6:41. doi: 10.1186/1756-8722-6-41.

    PubMed 23782711

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 13 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 7 inclusion and 26 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

Overall Response Rate (time frame: Up to 24 months). 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 NCT01593410, 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 20 Sep 2017.

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