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

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 p...

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Published in:	International journal of hematology Vol. 79; no. 2; pp. 165 - 173
Main Authors:	TAKENAKA, Takeaki, ITOH, Kuniaki, MIKUNI, Chikara, DEURA, Kijoh, YAMADA, Takashi, MIZOROGI, Fumi, NAGOSHI, Haruhisa, TOMONAGA, Masao, HOTTA, Tomomitsu, KAWANO, Kohichi, TSUSHITA, Keitaro, HIRANO, Masami, SUZUKI, Takayo, SHIMOYAMA, Masanori, UTSUNOMIYA, Atae, MATSUDA, Shin, CHOU, Takaaki, SAI, Toshiaki, SANO, Masayuki, KONDA, Susumu, OHNO, Tatsuji
Format:	Journal Article
Language:	English
Published:	Tokyo Springer 01-02-2004 Springer Nature B.V
Subjects:	Adult Aged Antineoplastic Agents, Alkylating - administration & dosage Antineoplastic Agents, Alkylating - adverse effects Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Biological and medical sciences Chemotherapy Confidence intervals Cyclophosphamide - administration & dosage Cyclophosphamide - adverse effects Disease-Free Survival Female Hematologic and hematopoietic diseases Humans Immunodeficiencies. Immunoglobulinopathies Immunoglobulinopathies Immunopathology Japan Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis Male Medical sciences Melphalan - administration & dosage Melphalan - adverse effects Middle Aged Multiple Myeloma - drug therapy Multiple Myeloma - mortality Nitrosourea Compounds - administration & dosage Nitrosourea Compounds - adverse effects Prednisone - administration & dosage Prednisone - adverse effects Treatment Outcome Vincristine - administration & dosage Vincristine - adverse effects Asia Japan Antineoplastic agent Phase III trial Nitrosoureas Multiple myeloma Myeloma Alkaloid Randomization Immunoglobulinopathy Lymphoproliferative syndrome Melphalan Antimitotic Prednisolone Corticosteroid Immunopathology MP Hematology Antiinflammatory agent Malignant hemopathy Vincristine Symptomatology Alkylating agent Oxazaphosphinane derivatives Cyclophosphamide Combination chemotherapy Nitrogen mustard Adrenal hormone Combined treatment Randomized study Immunosuppressive agent Ranimustine Comparative study
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Summary:	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.
ISSN:	0925-5710 1865-3774
DOI:	10.1532/ijh97.03115