Response rate, durability of response, and survival after thalidomide therapy for relapsed multiple myeloma

Shaji K Kumar, Morie Gertz, Angela Dispenzieri, Martha Lacy, Susan M. Geyer, Nancy L. Iturria, Rafael Fonseca, Suzanne R. Hayman, John A. Lust, Robert A. Kyle, Philip R. Greipp, Thomas Elmer Witzig, S Vincent Rajkumar

Research output: Contribution to journalArticle

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Abstract

Objective: To assess response rate, duration of response, progression-free survival, and toxicity of thalidomide in patients with relapsed multiple myeloma. Patients and Methods: Thirty-two patients with relapsed multiple myeloma were entered into the study between April 29, 1999, and June 20, 2000. They were given oral thalidomide at a dosage of 200 mg/d for 2 weeks, which was then increased as tolerated to a maximum of 800 mg/d. The primary end point of the study was response rate. Results: The median age of the patients was 67 years (range, 36-78 years). Prior chemotherapy had failed in all patients, and stem cell transplantation had failed in 5 patients (16%). There were 10 confirmed responses, yielding a response rate of 31%. In addition, there was 1 unconfirmed partial response and 7 minimal responses with no complete responses. The median duration of response was 11.9 months (range, 3.7-20.3 months). Overall, 20 patients have died, and 26 patients have experienced disease progression. The median follow-up of surviving patients was 28.5 months (range, 19.3-34.0 months), with a median progression-free survival of 8.6 months (95% confidence interval [CI], 4.7-16 months). The median progression-free survival among the responding patients was 15.7 months (95% CI, 8.6-25.6 months). The median overall survival for the entire group was 22 months (95% CI, 10.6-35.9 months). The most common treatment-related nonhematologic toxic effects (grade ≥3) were neuropathy (16%), sedation (13%), febrile neutropenia (6%), and constipation (6%). Conclusions: Thalidomide is useful in the treatment of patients with relapsed multiple myeloma and produced durable response in approximately one third of patients, with median response duration of nearly 1 year.

Original languageEnglish (US)
Pages (from-to)34-39
Number of pages6
JournalMayo Clinic Proceedings
Volume78
Issue number1
StatePublished - Jan 1 2003

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Thalidomide
Multiple Myeloma
Survival
Therapeutics
Disease-Free Survival
Confidence Intervals
Febrile Neutropenia
Poisons
Stem Cell Transplantation
Constipation
Disease Progression

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Response rate, durability of response, and survival after thalidomide therapy for relapsed multiple myeloma. / Kumar, Shaji K; Gertz, Morie; Dispenzieri, Angela; Lacy, Martha; Geyer, Susan M.; Iturria, Nancy L.; Fonseca, Rafael; Hayman, Suzanne R.; Lust, John A.; Kyle, Robert A.; Greipp, Philip R.; Witzig, Thomas Elmer; Rajkumar, S Vincent.

In: Mayo Clinic Proceedings, Vol. 78, No. 1, 01.01.2003, p. 34-39.

Research output: Contribution to journalArticle

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abstract = "Objective: To assess response rate, duration of response, progression-free survival, and toxicity of thalidomide in patients with relapsed multiple myeloma. Patients and Methods: Thirty-two patients with relapsed multiple myeloma were entered into the study between April 29, 1999, and June 20, 2000. They were given oral thalidomide at a dosage of 200 mg/d for 2 weeks, which was then increased as tolerated to a maximum of 800 mg/d. The primary end point of the study was response rate. Results: The median age of the patients was 67 years (range, 36-78 years). Prior chemotherapy had failed in all patients, and stem cell transplantation had failed in 5 patients (16{\%}). There were 10 confirmed responses, yielding a response rate of 31{\%}. In addition, there was 1 unconfirmed partial response and 7 minimal responses with no complete responses. The median duration of response was 11.9 months (range, 3.7-20.3 months). Overall, 20 patients have died, and 26 patients have experienced disease progression. The median follow-up of surviving patients was 28.5 months (range, 19.3-34.0 months), with a median progression-free survival of 8.6 months (95{\%} confidence interval [CI], 4.7-16 months). The median progression-free survival among the responding patients was 15.7 months (95{\%} CI, 8.6-25.6 months). The median overall survival for the entire group was 22 months (95{\%} CI, 10.6-35.9 months). The most common treatment-related nonhematologic toxic effects (grade ≥3) were neuropathy (16{\%}), sedation (13{\%}), febrile neutropenia (6{\%}), and constipation (6{\%}). Conclusions: Thalidomide is useful in the treatment of patients with relapsed multiple myeloma and produced durable response in approximately one third of patients, with median response duration of nearly 1 year.",
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T1 - Response rate, durability of response, and survival after thalidomide therapy for relapsed multiple myeloma

AU - Kumar, Shaji K

AU - Gertz, Morie

AU - Dispenzieri, Angela

AU - Lacy, Martha

AU - Geyer, Susan M.

AU - Iturria, Nancy L.

AU - Fonseca, Rafael

AU - Hayman, Suzanne R.

AU - Lust, John A.

AU - Kyle, Robert A.

AU - Greipp, Philip R.

AU - Witzig, Thomas Elmer

AU - Rajkumar, S Vincent

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N2 - Objective: To assess response rate, duration of response, progression-free survival, and toxicity of thalidomide in patients with relapsed multiple myeloma. Patients and Methods: Thirty-two patients with relapsed multiple myeloma were entered into the study between April 29, 1999, and June 20, 2000. They were given oral thalidomide at a dosage of 200 mg/d for 2 weeks, which was then increased as tolerated to a maximum of 800 mg/d. The primary end point of the study was response rate. Results: The median age of the patients was 67 years (range, 36-78 years). Prior chemotherapy had failed in all patients, and stem cell transplantation had failed in 5 patients (16%). There were 10 confirmed responses, yielding a response rate of 31%. In addition, there was 1 unconfirmed partial response and 7 minimal responses with no complete responses. The median duration of response was 11.9 months (range, 3.7-20.3 months). Overall, 20 patients have died, and 26 patients have experienced disease progression. The median follow-up of surviving patients was 28.5 months (range, 19.3-34.0 months), with a median progression-free survival of 8.6 months (95% confidence interval [CI], 4.7-16 months). The median progression-free survival among the responding patients was 15.7 months (95% CI, 8.6-25.6 months). The median overall survival for the entire group was 22 months (95% CI, 10.6-35.9 months). The most common treatment-related nonhematologic toxic effects (grade ≥3) were neuropathy (16%), sedation (13%), febrile neutropenia (6%), and constipation (6%). Conclusions: Thalidomide is useful in the treatment of patients with relapsed multiple myeloma and produced durable response in approximately one third of patients, with median response duration of nearly 1 year.

AB - Objective: To assess response rate, duration of response, progression-free survival, and toxicity of thalidomide in patients with relapsed multiple myeloma. Patients and Methods: Thirty-two patients with relapsed multiple myeloma were entered into the study between April 29, 1999, and June 20, 2000. They were given oral thalidomide at a dosage of 200 mg/d for 2 weeks, which was then increased as tolerated to a maximum of 800 mg/d. The primary end point of the study was response rate. Results: The median age of the patients was 67 years (range, 36-78 years). Prior chemotherapy had failed in all patients, and stem cell transplantation had failed in 5 patients (16%). There were 10 confirmed responses, yielding a response rate of 31%. In addition, there was 1 unconfirmed partial response and 7 minimal responses with no complete responses. The median duration of response was 11.9 months (range, 3.7-20.3 months). Overall, 20 patients have died, and 26 patients have experienced disease progression. The median follow-up of surviving patients was 28.5 months (range, 19.3-34.0 months), with a median progression-free survival of 8.6 months (95% confidence interval [CI], 4.7-16 months). The median progression-free survival among the responding patients was 15.7 months (95% CI, 8.6-25.6 months). The median overall survival for the entire group was 22 months (95% CI, 10.6-35.9 months). The most common treatment-related nonhematologic toxic effects (grade ≥3) were neuropathy (16%), sedation (13%), febrile neutropenia (6%), and constipation (6%). Conclusions: Thalidomide is useful in the treatment of patients with relapsed multiple myeloma and produced durable response in approximately one third of patients, with median response duration of nearly 1 year.

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