A Randomized, Open label, Phase 2 Study of CNTO 328 (Anti-IL 6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma

Phase 1

• Conditions: Previously untreated symptomatic multiple myeloma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-007157-12-FR
• Lead Sponsor: Centocor BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-31
• Study Completion: 2013-04-11
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Age =18 years old
2. Subjects must have signed informed consent indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of < or = 2
4. Confirmed diagnosis of multiple myeloma (International Myeloma Working Group [IMWG] criteria) requiring treatment
5. Subject is not a candidate for high dose chemotherapy with stem cell transplantation due to:
a. Age = 65 years, or
b. In subjects < 65 years: presence of important comorbid condition(s) likely to have a negative impact on the tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review of these comorbid conditions and approval is required before randomization.
6. Measurable secretory disease, defined as either serum monoclonal paraprotein (M protein) = 1 g/dL or urine monoclonal (light chain) protein > 200 mg/24 hours
7. Have pretreatment clinical laboratory values meeting the protocol criteria within 14 days before treatment
8. Female subjects must be postmenopausal (at least 12 months since last menses),
surgically sterile, abstinent, or, if sexually active, be practicing an effective method
of birth control (eg, prescription oral contraceptives, contraceptive injections,
intrauterine device, double-barrier method, contraceptive patch, male partner
sterilization) before study entry, for the duration of study participation, and for
6 months after the last administration of study agent, and must have a negative
serum or urine pregnancy test within 1 week before beginning treatment. Men
must be sterilized or agree to use a double-barrier method of birth control and must
agree to not donate sperm during the study and for 6 months after the last
administration of study agent.
9. Subjects must be able to adhere to study visit schedule and all protocol requirements.
10. The anticipated life expectancy is such that the subject will be able to participate for the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS)
2. Diagnosis of Waldenström’s disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
3. Prior or current systemic therapy or stem cell transplantation for multiple myeloma (including, corticosteroids, clarithromycin, mAbs, immunotherapy, investigative therapy, or immunosuppressive therapy) with the exception of emergency use of a short course (maximum 4 days) of corticosteroids before treatment
4. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events
5. Radiation therapy within 14 days before treatment
6. Plasmapheresis within 14 days before treatment
7. Major surgery within 14 days before treatment
8. Transplanted solid organ, with the exception of a corneal transplant (= 3 months
before treatment)
9. History of allergic reaction or hypersensitivity to boron or mannitol, or known allergies or clinically significant reactions to murine, chimeric, or human proteins
10. Concurrent medical condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
11. Serious concurrent illness or history of uncontrolled heart disease such as unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, or clinically significant rhythm or conduction abnormality
12. Prior or concomitant malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has undergone potentially curative therapy and has no evidence of that disease for = 5 years
13. Vaccinated with live, attenuated vaccines within 4 weeks of the first administration of CNTO 328
14. Known infection with HIV, known hepatitis C infection, or known to be hepatitis B surface antigen positive
15. Use of any investigational agents within 30 days or 5 half lives (whichever is
longer) of treatment
16. Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified