Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld).

Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld). - Induction therapy for Myeloma, AlteRnating Bortezomib and LEnalidomide: MARBLE study/2013-NHO(Hematology)-02

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013773

Enrollment

Registered

2014-06-01

Start date

2014-10-20

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

Bortezomib-dexamethasone (Bd) alternating with Lenalidomide-dexamethasone (Ld)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age of patients older than 75 years. 2. Symptomatic multiple myeloma newly diagnosed by WHO criteria, are ineligible for autologous stem cell transplantation. 3. Patients with Measurable disease; M-protein level is more than 0.5g/dL for the IgG, IgA, or IgM type myeloma, M-protein level is more than 0.05g/dL for the IgD type, or urinary M-protein excretion is more than 200 mg/24-hour. 4. Performance status (ECOG) <= 2, or 3 due to osteolytic lesions alone. 5. Have pre-treatment clinical laboratoly values meeting the following criteria: * AST, ALT < 3.0xULN * Creatinine clearance >= 30 mL/min * Absolute neutrophil count (ANC) >= 1.0x10^9/L * Platelet count >= 50x10^9/L * Ejection fraction >= 50% * PaO2 >= 60mmHg or SpO2 >= 93% 6. Agreement to RevMate registration was obtained, patients can comply with the contents. 7. In patients on notice, and received an explanation enough for the contents of this study, patient consent was obtained in writing to participate in the study by the free will.

Exclusion criteria

Exclusion criteria: 1. Plasma cell leukemia, cardiac amyloidosis, POEMS syndrome. 2. Patients has >= Grade 2 peripheral neuropathy. 3. Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension. 4. Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection. 5. Recent operation history. 6. Myocardial infarction within 6 months of enrolment or deep vein thrombosis/ pulmonary embolism within 3 years. 7. Patient has active and advanced double cancer (simultaneous or within 5 years post remission). 8. Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody. 9. Patients with pneumonitis (interstitial pneumonia) or pulmonary fibrosis in clinical, or abnormal (high-resolution) chest CT findings bilateral lung regardless of the presence or absence of symptoms. 10. Patient has hypersensitivity to boron or mannitol. 11. Patient has psychiatric diseases or psychological symptoms. 12. Patient judged inappropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR)	—

Secondary

Measure	Time frame
Safety (toxicity and tolerability) Continuation rate of treatment Complete response rate Very good partial response rate Progression-free survival rate (PFS) Overall survival rate (OS) Time to response (TTR)	—

Countries

Japan

Contacts

Public ContactHiromi Ohno

National Hospital Organization Tokyo Medical Center Documents support clerk

HOhno@ntmc.hosp.go.jp03-3411-0111

Outcome results

None listed

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