Newly diagnosed elderly symptomatic multiple myeloma: phase 2 study

JRCT ID: jRCTs071180031

Registered date:05/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 28/11/2017
• Target sample size: 49
• Countries of recruitment: mone,Japan
• Study type: Interventional

Intervention(s)

scVRD induction : Four 3-week cycles of scVRD. Cycle 1, subcutaneous bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11, oral Lenalidomide 25 mg on days 1 to 14, and dexamethasone 40 mg/day on days 1, 4, 8, 11. Cycle2-4, subcutaneous bortezomib 1.3 mg/m2 on days 1, 8 and 15, Lenalidomide 25 mg on days 1 to 14, and dexamethasone 40 mg/day on days 1, 8 and 15.

scBor-plerixafor-G-CSF PBSC mobilization : subcutaneous bortezomib 1.3 mg/m2 on days 1 and 4, and subcutaneous plerixafor 0.24 mg/ kg on day 4 and G-CSF 10ug/kg on day1-5 and PBSCH after day 5. The collection goal is 2.0x10^6 CD34+ cells/kg.

High dose chemotherapy and PBSCT : subcutaneous bortezomib 1.3mg/m2 on days -4,-1, 3 and 6, L-PAM 70mg/m2 on days -3, and -2, and PBSCT at day 0.

IRD consolidation : Four 4-week cycles of oral ixazomib 4mg on days 1, 8 and 15, oral lenalidomide 15 mg on days 1 through 21 of each 28-days cycle, and dexamethasone 40 mg/day on days 1, 8 and 15.

Lenalidomide maintenance : 4-week cycles of oral lenalidomide 10 mg on days 1 through 21 of each 28-days cycle until disease progression or intolerable adverse event.

Outcome(s)

• Primary Outcome: Complete response (CR) rates after consolidation therapy.

Secondary Outcome

1. CR + stringent CR (sCR) rates after induction therapy.
2. CR + sCR rates after autologous stem cell transplantation.
3. sCR rates after consolidation therapy.
4. CR + sCR rates after maintenance therapy.
5. 3-years progression free survival (PFS)
6. 3-years overall survival (OS)
7. Incidence of adverse events.
8. Immunological complete response (iCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy.
9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy.
10. Detection of minimal residual disease (MRD) in autologous grafts.
11. QOL after induction, autologous stem cell transplantation, consolidation and maintenance therapy

Key inclusion & exclusion criteria

• Age minimum: >= 66age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

All the following criteria MUST be met:
1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
2) Measureable M protein in serum or urine.
3) Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.)
4) Age: 66-75 years old
5) Main Organ function is maintained
6) Those who are evaluated to be able to survive more than 3 months.
7) For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study.
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 have been obtained.

Exclude criteria

1) Non-secretory MM and plasma cell leukemia.
2) Patients HIV-positive
3) Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
4) Patients with a history of active malignancy during the past 5 years.
5) Patients with psychiatric disorders such as schizophrenia etc.
6) Pregnant women, pre-menopausal women, and lactating women.
7) History of hypersensitivity to mannitol or boron.
8) Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary
9) Those who are considered as inappropriate to register by attending physicians.
10) Pregnant women and cases that may become pregnant or breastfeeding during the study period.
11) Cases with a history of hypersensitivity tomannitol or boron.
12) Clinical findings include pneumonia (interstitial pneumonia), cases with pulmonary fibrosis, or chest CT (high resolution CT) with bilateral abnormal interstitial shadows (ground glass or lines) regardless of the presence or absence of symptoms. Cases with (shadow) (consult with a specialist doctor such as respiratory organs if necessary).
13) Cases with grade 2 or higher peripheral neuropathy at baseline.
14) Other cases that the doctor in charge judged to be inappropriate.

Related Information

• Primary Sponsor: Tanimoto Kazuki
• Secondary Sponsor: Akashi Koichi
• Source(s) of Monetary Support: Bristol-Myers Squibb Company,Bristol-Myers Squibb Company
• Secondary ID(s): UMIN000028421