Purpose: This study assessed the safety, tolerability, and response rate of bortezomib in combination with dexamethasone and/or doxorubibcin in patients with relapsed or refractory multiple myeloma.

Methods: Botezomib was administered 1.3mg/m2 on days 1, 4, 8, 11 of a 28-day cycle. Intravenous dexamethasone was administered 20–40mg/d on day 1–2, 4–5, 8–9,11–12, and 5 patients were also given 20mg/d doxorubibcin on day 1–4.

Results: Thirty relapsed or refractory myeloma patients (table 1) were enrolled; two patients could not be evaluated because they were lost to follow-up. Of the remaining patients 19 are male, 9 are female. Median age of the patients were 61(49–78). Median number of prior therapies was 4 (1–11). 22 of 28 patients who had been evaluated were assessable for response according to the EBMT criteria (European Group for Blood and Marrow Transplantation criteria). One CR(3.6%), twelve immunofixation-positive CRs[nCR] (42.9%), six PRs(21.4%), and three MR (10.7%) were observed. All patients who had an objective response were alive as of this analysis. Nine patients died during follow-up. Mean response time (time to best response)for the 28 patients was 25 days. Most common Grade ≥3 toxicities (table 2) were peripheral neuropathy(3/28), thrombocytopenia (3/28), rash(one in 28 patients). Six patients(21.4%) suffered herpes after one or two cycles.

Table 1. Patents and Disease Characteristics (N=28)

No.%
Abbreviations: Ig, immunoglobulin; 
Parameter 61 49–78  
Age, years Median Range 19  
Sex Male Female 9  
Paraprotein type IgG IgA Light-chain only 18  
β2..Cmicroglubulin, 3 64.3 10.7 
Range 7 25.0 
Prior treatments 1262–8691  
Median 4  
Range 1–11  
No.%
Abbreviations: Ig, immunoglobulin; 
Parameter 61 49–78  
Age, years Median Range 19  
Sex Male Female 9  
Paraprotein type IgG IgA Light-chain only 18  
β2..Cmicroglubulin, 3 64.3 10.7 
Range 7 25.0 
Prior treatments 1262–8691  
Median 4  
Range 1–11  
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Table 2. Treatment-emergent adverse events

Total No. of patients with event(%)
Adverse event 0 
Hematologic Neutropenia No. with 3(10.7) 
grade ≥3 event Thrombocytopenia No. 0 
with grade ≥3 event Anemia No. with 6(21.4) 
grade ≥3 event 5(17.8) 
Nonhematologic herpes Diarrhea 10(35.7) 
Fatigue Rash No. with 1(3.6) 
grade ≥3 event Tachycardia Peripheral 1(3.6) 
neuropathy Total No. No. 16(57.1) 
with grade ≥ 3 event 3(10.7) 
Total No. of patients with event(%)
Adverse event 0 
Hematologic Neutropenia No. with 3(10.7) 
grade ≥3 event Thrombocytopenia No. 0 
with grade ≥3 event Anemia No. with 6(21.4) 
grade ≥3 event 5(17.8) 
Nonhematologic herpes Diarrhea 10(35.7) 
Fatigue Rash No. with 1(3.6) 
grade ≥3 event Tachycardia Peripheral 1(3.6) 
neuropathy Total No. No. 16(57.1) 
with grade ≥ 3 event 3(10.7) 
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Conclusion: Bortezomib plus dexamethasone given on a 28-day schedule showed encouraging activity with manageable toxicity and represents a promising treatment for multiple myeloma patients.

Topics:
bortezomib, dexamethasone, multiple myeloma, adverse event, exanthema, immunoglobulins, thrombocytopenia, toxic effect, anemia, antigens, cd98 light chains

Disclosures: Jin: Xi’an Janssen Pharmaceutical Ltd.: Research Funding. Qian: Xi’an Janssen Pharmaceutical Ltd.: Research Funding. Meng: Xi’an Janssen Pharmaceutical Ltd.: Research Funding. Qian: Xi’an Janssen Pharmaceutical Ltd.: Research Funding. Tong: Xi’an Janssen Pharmaceutical Ltd.: Research Funding. Tong: Xi’an Janssen Pharmaceutical Ltd.: Research Funding. Mao: Xi’an Janssen Pharmaceutical Ltd.: Research Funding.

Author notes

Corresponding author

2008, The American Society of Hematology
2008
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