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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00622336
First received: February 14, 2008
Last updated: September 19, 2012
Last verified: September 2012
  Purpose

To evaluate the safety of CC-5013 monotherapy in subjects with advanced multiple myeloma who 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.


Condition Intervention Phase
Multiple Myeloma
Drug: CC-5013
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Single-Arm Study of the Safety and Efficacy of CC-5013 Monotherapy for Subjects With Multiple Myeloma: A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Up to 70 months ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events


Secondary Outcome Measures:
  • Time to progression [ Time Frame: Up to 70 months ] [ Designated as safety issue: No ]
    Time to progression based on the Myeloma response determination criteria developed by Bladé et al 1998

  • Myeloma Response Rate [ Time Frame: Up to 70 months ] [ Designated as safety issue: No ]
    Myeloma response determination criteria developed by Bladé et al 1998

  • Duration of Response Rate [ Time Frame: Up to 70 months ] [ Designated as safety issue: No ]
    Duration of response based on the Myeloma response determination criteria developed by Bladé et al 1998


Estimated Enrollment: 700
Study Start Date: April 2003
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide 25mg (CC-5013)
Oral 25mg daily on Days 1-21 every 28 days
Drug: CC-5013
Oral 25mg daily on Days 1-21 every 28 days.
Other Names:
  • Revlimid
  • lenalidomide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age ≥ 18 years at time of signing the informed consent form.
  • Have 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 must agree to using two methods of contraception

Exclusion Criteria:

  • 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 patient from signing the informed consent form or that will place the subject 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 malignancy, other than multiple myeloma, (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622336

Locations
Russian Federation
Republican Clinical Hospital #1
Izhevsk, Russian Federation, 426039
Nizhny Novgorod Clinical Hospital n.a.Semashko
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk State Regional Clinical
Novosibirsk, Russian Federation, 630087
Samara Regional Clinical Hospital
Samara, Russian Federation, 443095
Ukraine
Kharkov Postgraduate Medical Academy Kharkov Regional Clinical
Kharkov, Ukraine, 61070
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
Kiev, Ukraine, 04060
Odessa Regional Clinical Hospital
Odessa, Ukraine, 65025
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Robert Knight, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00622336     History of Changes
Other Study ID Numbers: CC-5013-MM-012, 2004-002102-30
Study First Received: February 14, 2008
Last Updated: September 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Multiple Myeloma
Revlimid

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014