Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.

Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma. - FBMTG-EMM13

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010166

Enrollment

Registered

2013-03-06

Start date

2013-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

Induction therapy 1-2 cycles: Bortezomib 1.3mg/m2 sc (day1,4,8,11), cyclophosphamide 500mg/m2 po/iv (day1, 8), dexamethasone 40mg/body po/iv (day 1,4,8,11) 3-4 cycles: Bortezomib 1.3mg/m2 sc (day1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group(IMWG). 2) Measureable M protein in serum or urine. 3) ECOG performance status of 0 or 2 (PS 3 possible only for osteolytic lesions.) 4) Age 66-75 years 5) Adequate organ function 6) A life expectancy of at least 3 months 7) Female patients with post menoposal status and the last menstrual period>12 months prior to enrollment in trial, or patients who agree to contraception during the study. 8) Voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1) Nonsecretory MM and plasma cell leukemia. 2) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C. 3) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases) 4) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0). 5) History of malignant tumors (except for completely resected in situ carcinoma) during the previous 5 years. 6) Severe uncontrolled psychiatric disorder or illness. 7) Pregnant or lactating female 8) History of hypersensitivity to mannitol or boron. 9) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities. 10) Prior steroids treatment (allowed if short term treatment for their general condition or reduction the number of cancer cells) 11) Unwillingness or inability to follow the procedures required in the protocol.

Design outcomes

Primary

Measure	Time frame
Response rate: sCR+CR+VGPR rate 100 days after autologous PBSCT	—

Countries

Japan

Contacts

Public ContactFBMTG Study Office

Fukuoka Blood and Marrow Transplantation Group EMM13 DC

fbmtg@intmed1.med.kyushu-u.ac.jp092-642-5315

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026