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

NCT01593410 | Completed Phase 2

• 1 other identifier: CC-5013-MM-021
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

Multiple Myeloma

Keywords

Efficacy/Safety; Lenalidomide and Low-Dose Dexamethasone; Chinese Subjects; Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

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

  Up to 24 months

Secondary Outcomes (10)

• Adverse Events

  Up to 24 months

• Progression Free Survival (PFS)

  Up to 24 months

• Overall Survival

  Up to 24 months

• Response duration

  Up to 24 months

• Maximum observed concentration in plasma

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

Study Arms (1)

Lenalidomide and dexamethasone

EXPERIMENTAL

Cycle 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.

Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

25 mg oral lenalidomide once daily on Days 1-21 every 28 days

Also known as: Revlimid

Lenalidomide and dexamethasone

Dexamethasone DRUG

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

Lenalidomide and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (13)

307 Hospital of Chinese PLA

Beijing, 100071, China

Location

Peking University Third Hospital

Beijing, 100081, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, 300200, China

Location

Xiangya Hospital of Central- South University

Changsha, 410008, China

Location

Guangdong General Hospital

Guangzhou, 510080, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, 510515, China

Location

The First Hospital Affiliated of College Medicine, Zhejiang University

Hangzhou, 310003, China

Location

The First Hospital Affiliated of College Medicine, Zhejiang University

Hangzhou, 310009, China

Location

Shanghai Changzheng Hospital

Shanghai, 200003, China

Location

Shanghai 6th People's Hospital

Shanghai, 200233, China

Location

Changhai Hospital

Shanghai, 200433, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Related Publications (1)

• 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.

  PMID: 23782711 BACKGROUND

Related Links

• Link to CSR synopsis

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jay Mei, M.D.

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 8, 2012
• Study Start: August 1, 2010
• Primary Completion: January 3, 2013
• Study Completion: January 3, 2013
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

CN (13)