Randomized Phase II Study in Elderly Patients With Newly Diagnosed Multiple.

• Status: Not yet recruiting
• Trial end date: 2027-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy and safety of bortezomib, lenalidomide and dexamethasone in elderly frail patients with newly diagnosed multiple myeloma

1. Primary Study Objective

• Progression-Free Survival

: The time from randomization into the date of first observation of documented disease progression or any-kinds of death.

2. Secondary Study Objectives 1) Complete Response (CR)

• Response will be determined by the International Myeloma Working Group Response Criteria

• CR is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytoma and < 5% of plasma cells in bone marrow aspirates

• The determination of stringent CR and Imaging will be done 2) Overall response rate consisting of complete response, very good partial response, and partial response 3) Overall survival (OS)

• The time from randomization into the date of any-kinds of death. 4) Time to next treatment

• The time from randomization into the first date of second-line treatment. 5) Toxicity profiles

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone acetate; Lenalidomide

Criteria

Inclusion Criteria:

1. Newly diagnosed with multiple myeloma

2. Older than 70 years

3. Ineligible for autologous stem cell transplantation

4. No history of prior treatment for multiple myeloma

5. At least one of the following measuarble disease

• Serum M-protein ≥ 0.5 g/dL, or urine M-protein ≥ 200mg/24 hour, or

• In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa/lambda ratio.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

7. Adequate hepatic functionwith bilirubin < 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.

8. Left ventricular ejection fraction (LVEF) ≥ 40%.

9. Absolute neutrophil count (ANC) ≥ 1000/mm³: Screening ANC should be independent of growth factor support for ≥ 1 week

10. Hemoglobin ≥ 8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell transfusions is allowed); Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ -if myeloma involvement in the bone marrow is >50%): Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.

11. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

• Calculation should be based on standard formula such as the Cockcroft and Gault:

[(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female.

12. Written informed consent in accordance with institutional guidelines.

13. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide.

Effective method of contraception should be used during and for 28 days following last dose of drug

• FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

14. Male patients must use an effective barrier method of contraception during study and for 28 days following the last dose if sexually active with a FCBP.

Exclusion Criteria:

1. Relapsed or refractory multiple myeloma

2. Multiple Myeloma of IgM subtype.

3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).

4. Plasma cell leukemia or circulating plasma cells ≥ 2 × 10^9/L.

5. Waldenstrom's Macroglobulinemia.

6. Patients with known amyloidosis.

7. Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to the 1st day of 1st cycle.

8. Focal radiation therapy within 7 days prior to the 1st day of 1st cycle.

9. Immunotherapy within 21 days prior to the 1st day of 1st cycle.

10. Major surgery (excluding kyphoplasty) within 28 days prior to 1st day of 1st cycle.

11. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to 1st day of 1st cycle.

12. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to 1st day of 1st cycle.

13. Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).

14. Patients with known cirrhosis.

15. Female patients who are pregnant or lactating.

16. Patients with contraindication to dexamethasone.

17. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.

18. Patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis