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Clinical Trials List

Protocol NumberCC-4047-MM-007
NCT Number(ClinicalTrials.gov Identfier)NCT01734928

2015-04-01 - 2022-04-22

Phase III

Terminated7

ICD-10C90.02

Multiple myeloma in relapse

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LD-DEX) versus Bortezomib and Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma (MM)

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Celgene Corporation

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 張正雄 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 黃文豊 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Po-Nan Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Shang-Yi Huang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Relapsed or Refractory Multiple Myeloma (MM)

Objectives

Study Objectives To compare the efficacy of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM Secondary Objectives: To evaluate the safety and additional efficacy of POM + BTZ + LD-DEX versus BTZ + LDDEX in subjects with relapsed or refractory MM. Exploratory Objectives:  To explore the pharmacokinetics of pomalidomide and the relationship between drug exposure and response (pharmacodynamic effects, safety and/or efficacy as appropriate) in subjects with relapsed or refractory MM treated with pomalidomide  To evaluate the differences in pharmacoeconomics of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with relapsed or refractory MM  To evaluate the differences in clinical benefits of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with relapsed or refractory MM  To evaluate the differences in key efficacy variables of POM + BTZ + LD-DEX versus BTZ + LD-DEX within defined subgroups  To evaluate the differences in health-related quality of life of POM + BTZ + LDDEX versus BTZ + LD-DEX in subjects with relapsed or refractory MM  To evaluate Minimal Residual Disease (MRD), genomic, molecular/mechanistic and immune biomarkers and their correlation to clinical outcome measures for only those subjects who give their consent (Optional)

Test Drug

Pomalidomide

Active Ingredient

Pomalidomide

Dosage Form

capsule

Dosage

1 mg, 2 mg, 3 mg & 4 mg

Endpoints

Overview of Efficacy Assessments
 Myeloma paraprotein (M-protein)
 Serum immunoglobulins
 Serum Free Light Chain
 Corrected serum calcium
 Bone marrow aspiration/biopsy
 Radiographic assessments of lytic bone lesions (skeletal survey)
 Extramedullary plasmacytoma (EMP) assessments

Overview of Safety Assessments
 Complete physical examination including vital signs
 Clinical laboratory evaluations (hematology, serum chemistry, urinalysis)
 Venous thromboembolism (VTE) monitoring
 Pregnancy testing / counseling
 Electrocardiogram (ECG)
 Concomitant medications and procedures
 AEs
 Second primary malignancies will be monitored as events of interest and should be
included as part of the assessment of adverse events throughout the course of the
study. Investigators are to report any second primary malignancies as serious adverse
events regardless of causal relationship to study treatment (pomalidomide,
bortezomib or dexamethasone), occurring at any time from the time of signing the
informed consent up to and including the long-term follow-up period.
Overview of Other Assessments
 Eastern Cooperative Oncology Group (ECOG) performance status
 Cytogenetics
 Beta-2 microglobulin (β2M)
 Pharmacokinetics (Treatment Arm A only)
 Hospital / Emergency department utilization
 Quality of Life (QoL) questionnaires (if permitted by local regulations)
 The European Organization for Research and Treatment of Cancer QoL
Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20)
Module
 The European Organization for Research and Treatment of Cancer QoL
Questionnaire for Patients with Cancer (EORTC QLQ-C30) Module
 The descriptive system of the EQ-5D
 Bone marrow and blood samples for Minimal Residual Disease (MRD), genomic,
molecular/mechanistic and immune biomarkers at sites permitted by local regulations,
where operationally and logistically feasible, and only for subjects who consent to
participate in the optional biomarker study (Optional)

Inclution Criteria

Inclusion Criteria:
• Must be ≥ 18 years at the time of signing informed consent.
• Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
• Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
• Must have documented disease progression during or after their last anti-myeloma therapy.
• All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Exclusion Criteria

Exclusion Criteria:
• Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
• Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
• Non-secretory multiple myeloma.
• Subjects with severe renal impairment requiring dialysis.
• Previous therapy with pomalidomide.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    782 participants

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