Phase II trial of the clinical efficacy and safety of treatment combinations including consolidation with lenalidomide/daratumumab/dexamethasone for transplant-eligible patients with previously untreated multiple myeloma

Phase II trial to evaluate the clinical efficacy and safety of lenalidomide/bortezomib/dexamethasone induction, autologous transplantation, lenalidomide/daratumumab/dexamethasone consolidation and lenalidomide maintenance for transplant-eligible patients with previously untreated multiple myeloma - Phase II trial of BLd induction, ASCT, DLd consolidation and Len mentenaice for transplant-eligible previously untreated multiple myeloma patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200043

Enrollment

Registered

2020-08-20

Start date

2020-09-10

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 Multiple Myeloma

Interventions

Induction: BLd (bortezomib 1.3mg/m2 day 1, 8, 15, lenalidomide 25mg/day day 1-14, dexamethasone 40mg/body day 1, 8, 15 /every 3 weeks) x 4 cycles Peripheral blood stem cell harvest: cyclophosphamide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age from 20 to 69 years old 2. Symptomatic multiple myeloma diagnosed by the criteria of IMWG 3. Measurable M protein in serum or urine or abnormal kappa/lambda ratio by the serum free light chain measurement 4. ECOG Performance Status 0-2 5. Main organ function is maintained 6. Those who are expected to survive more than 3 months. 7. Patients who can comply with lenalidomide drug management procedures (RevMate). 8. 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 having been obtained.

Exclusion criteria

Exclusion criteria: Exclusion Criteria1. Non-secretory multiple myeloma and plasma cell leukemia. 2. Patients HIV-positive, HBs antigen positive, and HCV antibody positive. 3. History of hypersensitivity to mannitol or boron. 4. Pregnant women or lactating women. 5. Patients with a history of active malignancy during the past 5 years. 6. Patients with psychiatric disorders such as schizophrenia. 7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 8. Patient with clinically suspected interstitial pneumonia or pulmonary fibrosis. 9. Those who are considered as inappropriate to register by attending physicians.

Design outcomes

Primary

Measure	Time frame
CR rate before maintenance therapy	—

Secondary

Measure	Time frame
Response rate, incidence of adverse events, progression free survival, overall survival, time to progression, the number of harvested stem cells, incidence of graft failure, completion rate of maintenance, rate of minimal residual disease negativity	—

Contacts

Public ContactJunya Kanda

Graduate School of Medicine, Kyoto University

jkanda16@kuhp.kyoto-u.ac.jp+81-75-751-3152

Outcome results

None listed

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