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

NCT04277845 | Unknown Phase 2

• 1 other identifier: SMC 2019-08-025
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 3-Year Progression-free survival (PFS)

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

  3-years after randomization

Secondary Outcomes (1)

• Assessment of response

  accessed every each cycle (each cycle is 28days)

Other Outcomes (1)

• Minimal residual disease (MRD)

  at the time when patient get CR or VGPR after 1year administration

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1: 1 cycle will be repeated every 4 weeks Bortezomib 1.3mg/m2 SC D1, 8, 15 - Dose adjustment for more than 85 : 1.0mg/m2 SC D1, 8, 15 Lenalidomide 25mg/d D1-21 \- Dose adjustment for more than 75 : 15mg/d D1-21 Dexamethasone 40mg D1, 8, 15, 22 - Dose adjustment for more than 75 years old: 20mg If it is difficult to maintain bortezomib due to unacceptable toxicity, it can early discontinue from Group 1. \<for patients with old age or frail\> Bortezomib 1.0mg/m2 SC D1, 8, 15 : Dose adjustment for more than 85 : 1.0mg/m2 SC D1,8,15 Lenalidomide 15mg/d D1-21 Dexamethasone 20mg D1, 8, 15, 22

Drug: Bortezomib, Lenalidomide, Dexamethasone

Group 2

ACTIVE COMPARATOR

Group 2: 1 cycle will be repeated every 4 weeks Lenalidomide 25mg/d D1-21 * Dose adjustment for more than 75: 15mg Dexamethasone 40mg D1, 8, 15, 22 * Dose adjustment for more than 75: 20mg \<for patients with old age or frail\> 1. Lenalidomide 15mg/d D1-21 2. Dexamethasone 20mg D1, 8, 15, 22

Drug: Bortezomib, Lenalidomide, Dexamethasone

Interventions

Bortezomib, Lenalidomide, Dexamethasone DRUG

Bortezomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone

Also known as: Lenalidomide, Dexamethasone

Group 1; Group 2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Newly diagnosed with multiple myeloma
• Older than 70 years
• Ineligible for autologous stem cell transplantation
• No history of prior treatment for multiple myeloma
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• 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.
• Left ventricular ejection fraction (LVEF) ≥ 40%.
• \*Absolute Neutrophil Count (ANC) ≥ 1000/mm³: Screening ANC should be independent of growth factor support for ≥ 1 week;
• 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.
• Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

You may not qualify if:

• Relapsed or refractory multiple myeloma
• Multiple Myeloma of IgM subtype.
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• Plasma cell leukemia or circulating plasma cells ≥ 2 × 10\^9/L.
• Waldenstrom's Macroglobulinemia.
• Patients with known amyloidosis.
• Patients got approved chemotherapy or investigational anticancer therapeutics within 21 days prior to the 1st day of 1st cycle.
• Focal radiation therapy within 7 days prior to the 1st day of 1st cycle.
• Immunotherapy within 21 days prior to the 1st day of 1st cycle.
• Major surgery (excluding kyphoplasty) within 28 days prior to 1st day of 1st cycle.
• 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.
• 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.
• Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (But, allow the patient who is DNA(-) or responding to antiviral therapy even if patient is HBsAg(+) or anti-HBc(+)).
• Patients with known cirrhosis.
• Female patients who are pregnant or lactating.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 20, 2020
• Study Start: August 6, 2020
• Primary Completion: March 23, 2022
• Study Completion: March 1, 2025
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

KR (1)