Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma

Phase II study evaluating safety and efficacy of induction therapy with small-dose bortezomib, lenalidomide and dexamethasone combination for previously untreated symptomatic multiple myeloma - HCHSG-MM-214

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016265

Enrollment

Registered

2015-01-19

Start date

2015-01-19

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

&lt

BD therapy

1 course&gt

Dexamethasone 40 mg/day (day 1, 8, 15, 22) and subcutaneous injection of bortezomib 1.3 mg/m2/day (day 1, 15), one course in 28-day cycle. &lt

small BLD (sBLD) therapy

12 courses&gt

Lenalidomide 10 mg day (day 1-21), dexamethasone 40 mg/day (day 1, 8, 15, 22) and subcutaneous injection of bortezomib 1.3 mg/m2/day (day 1, 15), 12 courses in 28-day cycle.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Previously untreated symptomatic multiple myeloma who are not candidates for stem cell transplantation. Measureable M protein in serum or urine. Good performance status (0-2). Patients with bad performance status due to osteolytic lesions can be included. Age more than 20 years old. Main Organ function is maintained. Those who are evaluated to be able to survive more than 3 months. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained.

Exclusion criteria

Exclusion criteria: Non-secretory multiple myeloma or plasma cell leukemia. HIV-, HBs-, or HCV-positive patients. Severe or uncontrolled hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction, diabetes, hypertension, infection, or psychiatric disorder. Patients with active and progressive malignancy. Women who are pregnant or in lactation. Those who are considered as inappropriate to register by attending physicians.

Design outcomes

Primary

Measure	Time frame
Response rate Incidence of adverse events	—

Countries

Japan

Contacts

Public ContactTsutomu Sato

Sapporo Medical University Hospital Fourth Department of Internal Medicine

tsutomus@sapmed.ac.jp011-611-2111

Outcome results

None listed

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