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International Journal of Hematology

, Volume 79, Issue 2, pp 165–173 | Cite as

Phase III Study of Ranimustine, Cyclophosphamide, Vincristine, Melphalan, and Prednisolone (MCNU-COP/MP) versus Modified COP/MP in Multiple Myeloma: A Japan Clinical Oncology Group Study, JCOG 9301

  • Takeaki Takenaka
  • Kuniaki Itoh
  • Takayo Suzuki
  • Atae Utsunomiya
  • Shin Matsuda
  • Takaaki Chou
  • Toshiaki Sai
  • Masayuki Sano
  • Susumu Konda
  • Tatsuji Ohno
  • Chikara Mikuni
  • Kijoh Deura
  • Takashi Yamada
  • Fumi Mizorogi
  • Haruhisa Nagoshi
  • Masao Tomonaga
  • Tomomitsu Hotta
  • Kohichi Kawano
  • Keitaro Tsushita
  • Masami Hirano
  • Masanori ShimoyamaEmail author
  • Lymphoma Study Group of the Japan Clinical Oncology Group
Case Report

Abstract

To investigate whether combination chemotherapy with vincristine, cyclophosphamide, prednisolone, and melphalan (COP/ MP) with the addition of ranimustine (MCNU) (MCNU-COP/MP) is superior to the slightly modified COP/MP (mCOP/MP) regimen in multiple myeloma (MM), a multicenter randomized study was performed. Two hundred ten patients with newly diagnosed, overt MM not treated with chemotherapy were enrolled from 32 institutions of the Lymphoma Study Group of the Japan Clinical Oncology Group and were randomized to receive either MCNU-COP/MP or mCOP/MP. The response rate (RR) to mCOP/MP was 43.7% (95% confidence interval [CI], 33.9%–53.8%] and to MCNU-COP/MP was 56.1 % (95% CI, 46.1 %–65.7%) (P = .097). The progression-free survival (PFS) was significantly longer for patients treated with MCNU-COP/MP than for patients treated with mCOP/MP (median, 23.0 months [95% CI, 18.9–25.8] versus 15.8 months [95% CI, 14.1–19.4]) (P = .014). However, no significant difference in overall survival rate (OS) was observed between the groups (median, 49.9 months [95% CI, 40.4-59.1] versus 44.0 months [95% CI, 32.8–59.8]) ( P = .75). Grades 3 and 4 hematological toxicities were more frequently observed with MCNU-COP/MP than with mCOP/MP, but the incidence of grades 3 and 4 nonhematological toxicities was low in both groups. In conclusion, MCNU-COP/MP in comparison with mCOP/MP improved RR and PFS in overt MM; however, this outcome did not contribute to prolonging OS, indicating that addition of MCNU to mCOP/MP has no benefit on survival.

Key words

Ranimustine MP Combination chemotherapy Randomized study Multiple myeloma 

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Copyright information

© The Japanese Society of Hematology 2004

Authors and Affiliations

  • Takeaki Takenaka
    • 1
  • Kuniaki Itoh
    • 2
  • Takayo Suzuki
    • 3
  • Atae Utsunomiya
    • 4
  • Shin Matsuda
    • 5
  • Takaaki Chou
    • 6
  • Toshiaki Sai
    • 7
  • Masayuki Sano
    • 8
  • Susumu Konda
    • 9
  • Tatsuji Ohno
    • 10
  • Chikara Mikuni
    • 11
  • Kijoh Deura
    • 12
  • Takashi Yamada
    • 13
  • Fumi Mizorogi
    • 14
  • Haruhisa Nagoshi
    • 15
  • Masao Tomonaga
    • 16
  • Tomomitsu Hotta
    • 17
  • Kohichi Kawano
    • 18
  • Keitaro Tsushita
    • 19
  • Masami Hirano
    • 20
  • Masanori Shimoyama
    • 21
    Email author
  • Lymphoma Study Group of the Japan Clinical Oncology Group
  1. 1.Hematology DivisionNational Cancer Center HospitalTokyo
  2. 2.Division of Hematology/OncologyNational Cancer Center Hospital EastKashiwa
  3. 3.Division of Hematology/OncologyShiga Medical Center for AdultsShiga
  4. 4.Department of Internal MedicineImamura Bun- in HospitalKagoshima
  5. 5.Ohla Nishinouchi HospitalKoriyama
  6. 6.Departments of Internal MedicineNiigata Cancer Center Niigata HospitalNiigata
  7. 7.Iwaki- Kyoritsu General HospitalIwaki
  8. 8.Saga Medical SchoolSaga
  9. 9.Department of Hematology and ImmunologyKanazawa Medical UniversityKahoku
  10. 10.Departments of Internal MedicineOhtsu Red Cross HospitalOhtsu
  11. 11.Sapporo National HospitalSapporo
  12. 12.Saku Central HospitalSaku
  13. 13.Jikei University Aoto HospitalTokyo
  14. 14.Daisan HospitalJikei UniversityKomae
  15. 15.St, Marianna University HospitalKawasaki
  16. 16.Department of Hematology, Molecular Medicine Unit, Atomic Bomb Disease InstituteNagasaki UniversityNagasaki
  17. 17.Fourth Department of Internal MedicineTokai UniversityIsehara
  18. 18.Department of Internal MedicineKyorin UniversityMitaka
  19. 19.Departments of HematologyNagoya National HospitalNagoya
  20. 20.Fujita Health UniversityToyoake
  21. 21.Medical Oncology DivisionNational Cancer Center HospitalTokyoJapan

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