Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma

NCT00153933 | Completed Phase 1

• 1 other identifier: 04-130
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose if this study is to evaluate the side effects of the combination of bortezomib and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.

Conditions

Refractory Multiple Myeloma; Relapsed Multiple Myeloma; Multiple Myeloma

Keywords

Multiple Myeloma; bortezomib; Revlimid; CC-5013

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of bortezomib when given in combination with CC-5013 in subjects with relapsed and relapsed/refractory multiple myeloma, to identify the MTD as well as a RP2D.

  2 years

Secondary Outcomes (2)

• To evaluate the response of the combination of bortezomib and CC-5013

• To determine the pharmacokinetics of bortezomib and CC5013 in patients with multiple myeloma.

  2 years

Study Arms (1)

CC-5013 in combination with bortezomib

EXPERIMENTAL

Participants will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-days of rest. One cycle lasts 21 days.

Drug: Bortezomib; Drug: CC-5013

Interventions

Bortezomib DRUG

Given intravenously on days 1, 2, 8, 11 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.

Also known as: velcade

CC-5013 in combination with bortezomib

CC-5013 DRUG

Orally on days 1-14 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.

Also known as: Revlimid, Lenalidomide

CC-5013 in combination with bortezomib

Eligibility Criteria

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

You may qualify if:

• Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions.
• Must have relapsed or relapsed/refractory disease
• years of age or older
• All baseline studies must be performed within 21 days of enrollment.
• ECOG performance status of 0 to 2

You may not qualify if:

• Renal insufficiency (serum creatinine levels \> 2mg/dL)
• Concomitant therapy medications that include corticosteroids
• Peripheral neuropathy of Grade 3 or greater or painful Grade 2
• Evidence of mucosal or internal bleeding and/or platelet refractory
• ANC \< 1000 cells/mm3
• Hemoglobin \< 8.0 g/dL
• AST (SGOT and ALT) \> 2 x ULN
• Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
• Known hypersensitivity to thalidomide or the development of erythema nodosum
• Active infection or serious co-morbid medical condition
• Pregnant or breast-feeding women
• Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (6)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Center

Atlanta, Georgia, 30322, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; 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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paul Richardson, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 25, 2016

Record last verified: 2016-01

Locations

US (6)