Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- Lenalidomide
- Conditions
- Multiple Myeloma
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Combined Therapy - Median Progression Free Survival
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.
Detailed Description
Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1. Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the patient's disease is stable after 2 cycles of therapy, the use of an alternate corticosteroid (prednisone) will be added to the lenalidomide therapy they are receiving. Dexamethasone and prednisone are in tablet form and will be taken orally (by mouth). However, if the patient has a minimal response after an additional 2 cycles of lenalidomide therapy, the therapy will be continued until their disease progresses. See the intervention descriptions for further details.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Understand and voluntarily sign an informed consent form
- •Age ≥65 years or not eligible for high dose therapy and autologous stem cell transplant
- •Able to adhere to study visit schedule and other protocol requirements
- •Diagnosed with multiple myeloma and considered to have active disease. Patients must not have received an active chemotherapy regimen or Dexamethasone. Patients may have received palliative radiotherapy at least 2 weeks prior to the study start.
- •Measurable myeloma paraprotein levels in serum (≥ 0.5 g/dL), urine (≥ 0.2 g excreted in a 24-hour urine collection sample) or by serum free light chains (involved free light chain greater than 100mg/L)
- •Eastern Cooperative Group (ECOG) Performance Status of 0 or 1
- •Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the laboratory
- •Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) levels ≤2 x ULN
- •Adequate bone marrow function: Absolute neutrophil count ≥ 1,000 cells/mm³ (1.0 x 10\^9/L); Platelets ≥ 100,000 /mm³
- •Hemoglobin \> 8 g/dL
Exclusion Criteria
- •Ongoing severe infection requiring intravenous antibiotic treatment
- •Life expectancy of less than 3 months
- •Performance status of 2, 3 or 4
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the patient has been disease-free for at least 2 years
- •Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- •Uncontrolled medical problems such as diabetes mellitus, congestive heart failure, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Pregnant or lactating
- •Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Known hypersensitivity to thalidomide
Arms & Interventions
Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Intervention: Lenalidomide
Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Intervention: Prednisone
Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Intervention: Dexamethasone
Outcomes
Primary Outcomes
Combined Therapy - Median Progression Free Survival
Time Frame: up to 36 months
Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)
Secondary Outcomes
- Response Rate(Every 8 weeks up to 12 months)
- Number of Participants With 1 Year Overall Survival (OS)(1 Year)
- Number of Participants With Serious Adverse Events(Day 1 through Off Study Date, an average of 48 months)
- Single Agent - Median Progressive Free Survival (PFS)(First measure at 8 weeks)