Phase II sudy of cetuximab for the treatment of refractory or relapsed multiple myeloma Erbitux for Multiple MyelomA

Completed

• Conditions: Cancer; Relapsed or refractory multiple myeloma

• Registration Number: ISRCTN81968533
• Lead Sponsor: niversity of Cologne (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Multiple myeloma diagnosed according to the Durie-criteria in stage II or III (Salmon and Durie)
2. Measurable disease
3. Refractory or relapsed disease after at least one line of treatment
4. Male or female 18 years of age or older
5. Life expectancy more than 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performances status zero to two
7. If of childbearing potential, willingness to use effective contraceptive method for the study duration and six months post-dosing
8. No surgery, radiotherapy or chemotherapy or any investigational agent within four weeks of study entry
9. Signed written informed consent

Exclusion Criteria

1. Asecretory multiple myeloma
2. Patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation
3. Prior allogenic transplantation
4. Prior antibody or Epidermal Growth Factor Receptor (EGFR)-pathway targeting therapy
5. Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency more than the New York Heart Association-II
6. Human Immunodeficiency Virus (HIV) infection, Hepatitis B or C
7. Brain disorders, psychatric illness
8. Insufficient bone marrow reserve (leucocytes less than 1500/µl, thrombocytes less than 50000/µl)
9. Creatinine-clearance less than 50 ml/min or serum creatinine more than 1.8 mg/dl
10. Bilirubin more than 2 mg/dl, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) more than 100 U/l
11. Pregnancy (absence confirmed by serum/urine Beta-Human Chorionic Gonadotropin [Beta-HCG]) or breast-feeding
12. Pulmonary dysfunction
13. Active secondary malignancy
14. Legal incapacity or limited legal capacity
15. Having participated in another clinical trial or any investigational agent in the preceding 30 days
16. Known allergic/hypersensitivity reaction to any compounds of the treatment
17. Other previous malignancy within five years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
18. Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
19. Known drug abuse/alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess efficacy of Cetuximab in patients with refractory/relapsed multiple myeloma.

Secondary Outcome Measures

Name	Time	Method
1. Safety profile of Cetuximab with/without Dexamethasone<br>2. Freedom from treatment failure<br>3. Progression-free survival<br>4. Overall survival<br>5. Pharmacogenomic evaluation of response to treatment