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Phase II Study to evaluate efficacy and safety of Lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatment

Phase II Study to evaluate efficacy and safety of Lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatment - L-Defense study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013881
Enrollment
29
Registered
2014-05-05
Start date
2014-05-07
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

Lenalidomide 10-15mg/day (Day 1-21) p.o

Sponsors

National Defense Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who give written informed consent following sufficient explanation. 2. Patients who have been diagnosed as symptomatic multiple myeloma by the criteria of IMWG. 3. Patients who have measurable M protein or FLC in serum or urine. 4. Patients over 20 years old and not eligible for ASCT. 5. Female patients who are post menopause (patients older than one year from the last menstrual period), of the proper way of surgical contraception (birth control pill, contraceptives, etc.) and who have the intention of contraception during the lenalidmide therapy. Male patients who agree the appropriate method of contraception during the lenalidmide therapy. 6. Patients who have achieved the response more than PR in the initial treatment with bortezomib. There is no limitation on the period of response.

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant or lactating. 2. Patients who had been determined ineligible for any reason by physician. 3. Patients who have not achieved PR with bortezomib therapy as initial treatment. 4. Patients who progressed in disease status less than PR after the initial response.

Design outcomes

Primary

MeasureTime frame
best response rate

Countries

Japan

Contacts

Public ContactShinichi Kobayashi

National Defense Medical College Division of Hematology

kobashin@ndmc.ac.jp04-2995-1617

Outcome results

None listed

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