IPD-MM22 study

JRCT ID: jRCT2011230049

Registered date:19/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Newly-diagnosed multiple myeloma
• Date of first enrollment: 06/11/2023
• Target sample size: 55
• Study type: Interventional
• Intervention(s): Study treatment,Autologous Peripheral Blood Stem Cell Transplantation,blood test,bone marrow test

Outcome(s)

• Primary Outcome: Complete response rate after consolidation therapy (Isa-PD therapy)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1)Patients aged between 20 and less than 70 upon acquisition of consent (regardless of sex and hospitalization status).
2)Having multiple myeloma satisfying the IMWG diagnostic criteria (2014 revised edition).
Satisfying at least one of clonal plasma cells in bone marrow>-10%,osseous or extramedullary plasmacytoma demonstrated by biopsy and the below-given myeloma-defining events 1 or 2.
Myeloma-Defining Events
[events 1]:Organ failure possibly attributable to plasma cell proliferative disease.
-Hypercalcemia: Serum calcium level higher by more than 1 mg/dL than the upper limit of institution normal range (ULN) or higher than 11 mg/dL.
-Renal failure: Creatinine clearance < 40 mL/min or serum creatinine > 2 mg/dL.
-Anemia: Hemoglobin level lower by more than 2 g/dL than the lower limit of institution normal range (LLN) or lower than 10 g/dL.
-Bone lesions: One or more osteolytic lesions revealed by bone X-ray,CT or PET-CT
[events 2]:Satisfying at least one of the below-given biomarkers of malignant tumors.
-Percentage of monoclonal plasma cells in bone marrow >-60%.
-Free light chain ratio in serum >-100.
-Two or more focal bone lesions (>-5 mm) revealed by MRI.
3) Possible to measure M protein (indicator of responses to treatment) in serum or urine. Or the free light chain
concentration ratio in serum is abnormal (kappa/lambda ratio > 4:1 or <1:2).
-Serum M protein>-1 g/dL
-Urinary M protein>-200 mg (24-hour pooled urine)
-Free light chain concentration ratio in serum is abnormal and free light chain concentration >- 100 mg/L
4) Never having received treatment of multiple myeloma before (excluding radiotherapy for the purpose of painrelief related to bone lesions).
5) ECOG-PS 0 to 2(unless worsening of PS due to osteolytics lesion)
6) Internal organs and bone marrow functioning well,satisfying the following criteria:
-Absolute neutrophil count: >- 1,000/mm3
-Platelet count: >- 75,000/mm3
-Hemoglobin: >- 8.0 g/dL
-Creatinine clearance: >- 30 mL/min (converted with Cockcroft-Gault formula; eGFR30ml/min may be used as a substitute)
-Total bilirubin: Not exceeding twice the upper limit of institution normal range (ULN)
*This criterion is not applied to patients diagnosed definirely with Gilbert syndrome (persistent or relapsing
hyperbilirubinemia of mainly the unconjugated type,free of hemolysis or pathologic signs of liver).
Eligibility to the tria shall be judged by the Principal Investigator/Sub-investigator.
-Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): Not exceeding three times theupper limit of institution normal range (ULN).
7) Left ventricular ejection fraction (LVEF): >- 50%
8) SpO2 >- 93% (without oxygen therapy)
9) Expected survival >- 12 weeks
10) Female patients are eligible if they are postmenopausal(1 year or more after the last menstruation) or having agreed to comply with RevMate and to take surgical contraceptive measures or other appropriate contraceptive measures(contraceptive agents, devices) during the trial period and for 5 months after completion of the trial. Male patients are eligible if they have agreed to comply with RevMate and to take appropriate contraceptive measures during the trial period.
11) Patients having been informed sufficiently about the trial by the Principal Investigator/Sub-investigator using the preset consent form and other leaflets and having issued written consent to participation in the trial at their own discretion.

Exclude criteria

1) Patients with symptoms due to amyloidosis and histologically proven amyloid deposition.
2) Smoldering IgM myeloma, solitary plasmacytoma,plasmacytic leukemia, POEMS syndrome or Waldenstroem's macroglobulinemia.
3) Patients having received more than 20 mg/day steroid(converted to prednisolone dose) within 14 days before provisional enrollment.
4) Patients having received surgery (excluding minimaloperative procedures such as tooth extraction) within14 days before provisional enrollment.
5) Patients with myeloma cells invading the central nervous system.
6) Patients having Grade 2 or severer peripheral neuropathy (PN) at the baseline.
7) Patients with poorly controlled diabetes mellitus, hypertension or infection.
8) Patients having immunodeficiency or its history
9) Patients with severe mental disorders such as schizophrenia(excluding subjects judged by the attending
physician as being well controlled by medication).
10) Patients with severe or poorly controlled systemic disease(including predisposition to active bleeding, and
active infections such as hepatitis B,hepatitis C and human immunodeficiency virus (HIV) infection).
11) Patients having received a live attenuated vaccine within 30 days before provisional enrollment.
12) Patients with active double cancers at advanced stage(synchronous double cancers, and metachronous double cancers with a disease-free period not exceeding 5 years;provided the lesions of the uterine cervix, stomach or large bowel equivalent to carcinoma in situ and judged as curable by topical therapy shall be excluded from active double cancers).
13) Pregnant women, women possible to become pregnant during the trial period or lactating women.
14) Other patients judged as inappropriate for the trial by the Principal Investigator/Sub-investigator.

Related Information

• Primary Sponsor: Goto Hideki
• Source(s) of Monetary Support: Source of Monetary Support Sanofi K.K.