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

JRCT ID: jRCTs051200043

Registered date:20/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 10/09/2020
• Target sample size: 46
• Study type: Interventional

Intervention(s)

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 + G-CSF
Peripheral blood stem cell transplantation: melphalan 100mg/m2 day -2, -1
Consolidation: DLd (daratumumab 16mg/kg d.i.v. or 1800mg s.c. day 1, 15, lenalidomide 15mg/day day 1-21, dexamethasone 20mg/body day 1, 2, 15, 16, dexamethasone 40mg/body day 8, 22/ every 4 weeks) x 4 cycles
(Consolidation will be skipped for patients who achieved negative MRD post transplantation)
Maintenance: lenalidomide (10mg/day day 1-21 / every 4 weeks) continuously for at least 2 years (until PD is recommended)

Outcome(s)

• Primary Outcome: CR rate before maintenance therapy
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takaori-Kondo Akifumi
• Secondary Sponsor: Kanda Junya
• Source(s) of Monetary Support: Brisrol Myers Squibb,Brisrol Myers Squibb