A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma

NCT00622336 | Completed Phase 3 Results

• 2 other identifiers: CC-5013-MM-0122004-002102-30
• Study Type: interventional
• Target: 330
• Locations: 2 countries
• Sites: 7

Brief Summary

The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Revlimid

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AE) During the Treatment Phase

  An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

  Until data cut-off of 22 Oct 2009; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Maximum exposure to Lenalidomide treatment was 1260 days.

• Number of Participants With Adverse Events (AE) During the Extension Phase

  An AE is any sign, symptom, illness, or diagnosis (either observed or volunteered) that appears or worsens during the course of the study Serious adverse event (SAE) = any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. A treatment emergent AE is defined as any AE occurring or worsening on or after the first dose of study drug and within 30 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 2.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;

  From 22 Oct 2009 to November 2013; AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit.

Secondary Outcomes (3)

• Time to Progression

  Up to 70 months

• Myeloma Response Rate

  Up to 70 months

• Duration of Response

  Up to 70 months

Study Arms (1)

Lenalidomide 25mg (CC-5013)

EXPERIMENTAL

Oral 25mg daily on Days 1-21 every 28 days

Drug: CC-5013; Drug: Lenalidomide

Interventions

CC-5013 DRUG

Oral 25mg daily on Days 1-21 every 28 days.

Also known as: Revlimid, lenalidomide

Lenalidomide 25mg (CC-5013)

Lenalidomide DRUG

Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Also known as: Revlimid, CC-5013

Lenalidomide 25mg (CC-5013)

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 an informed consent form.
• Age ≥ 18 years at time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements
• Participants with multiple myeloma and were enrolled in either THAL-MM-003, CC-5013-MM-009, or CC-5013-MM-010 and discontinued study therapy with thalidomide and high-dose dexamethasone or high-dose dexamethasone alone due to:
• documented disease progression OR inability to tolerate the lowest dosing regimen allowed on previous protocol without a grade 3 or 4 toxicity.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0,1,2
• Recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (NCI CTC)
• Females of child-bearing potential (FCBP) must agree to using two methods of contraception

You may not qualify if:

• Prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior development of a grade ≥ 3 rash or desquamation while taking thalidomide National Cancer Institute Common toxicity Criteria (NCI CTC)
• Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
• Any serious medical condition, laboratory abnormality, or psychiatric illness that will prevent the participant from signing the informed consent form or that will place the participant at an unacceptable risk for toxicity if he/she participates in the study.
• Pregnant or lactating females.
• Prior therapy with CC-5013; prior history of malignancies, other than multiple myeloma (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast), unless subject has been free of disease for ≥ 5 years
• More than 4 months has elapsed since the last dose of study drug was administered on study Tal MM-003, CC-5013-MM-009, CC-5013-MM-010
• Absolute neutrophil count (ANC) \<1,000cells/mm\^3 (1.0 X 10\^9/L)
• Platelet count \<75,000/mm\^3 (30 X 10\^9/L) for those with \<50% if the bone marrow nucleated cells re plasma cells; Platelet count \<30,000/mm\^3 (30 X 10\^9/L) for those with \<50% if the bone marrow nucleated cells re plasma cells
• Serum creatinine \>2.5mg/dL; serum SGOT/AST or SGPT/ALT x upper limits of normal (ULN)
• Serum total bilirubin \>2.0mg/d/L

Sponsors & Collaborators

• Celgene: lead

Study Sites (7)

Republican Clinical Hospital #1

Izhevsk, 426039, Russia

Location

Nizhny Novgorod Clinical Hospital n.a.Semashko

Nizhny Novgorod, 603126, Russia

Location

Novosibirsk State Regional Clinical

Novosibirsk, 630087, Russia

Location

Samara Regional Clinical Hospital

Samara, 443095, Russia

Location

Kharkov Postgraduate Medical Academy Kharkov Regional Clinical

Kharkiv, 61070, Ukraine

Location

Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

Kiev, 04060, Ukraine

Location

Odessa Regional Clinical Hospital

Odesa, 65025, Ukraine

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide

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

Results Point of Contact

• Title: Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@celgene.com

1-888-260-1599

Study Officials

• Robert Knight, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: April 1, 2003
• Primary Completion: November 25, 2013
• Study Completion: November 25, 2013
• Last Updated: November 20, 2019
• Results First Posted: December 30, 2014

Record last verified: 2019-11

Locations

RU (4); UA (3)