Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

NCT01054144 | Completed Phase 2 Results DMC

• 3 other identifiers: MCC-16018108562RV-MM-PI-0454
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Newly Diagnosed Standard Risk Multiple Myeloma; Senior Adults

Outcome Measures

Primary Outcomes (1)

• Combined Therapy - Median Progression Free Survival

  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)

  up to 36 months

Secondary Outcomes (4)

• Response Rate

  Every 8 weeks up to 12 months

• 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

• Number of Participants With 1 Year Overall Survival (OS)

  1 Year

Study Arms (1)

Response Adapted Therapy

EXPERIMENTAL

Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.

Drug: Lenalidomide; Drug: Prednisone; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

* Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue

Also known as: Revlimid®

Response Adapted Therapy

Prednisone DRUG

* Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue

Response Adapted Therapy

Dexamethasone DRUG

* Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue

Also known as: Decadron

Response Adapted Therapy

Eligibility Criteria

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

You may qualify if:

• 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
• Adequate renal function: Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
• Low risk myeloma is defined as the absence of the following adverse features\[21\]: t(4;14) by FISH or metaphase cytogenetics; t(14,16) or t(14;20) by FISH or metaphase cytogenetics; Deletion 17q13 by FISH; Deletion 13 by metaphase analysis; Aneuploidy by metaphase analysis; Β2 microglobulin \> 5.5.
• Able to tolerate one of the following thromboprophylactic strategies: aspirin, low molecular weight heparin or warfarin (coumadin)
• Must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per milliliter (mIU/mL) within 10 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.

You may not qualify if:

• 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
• Use of any other experimental drug or therapy within 28 days of baseline.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• Any prior use of lenalidomide
• Concurrent use of other anti-cancer agents or treatments
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Celgene: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Prednisone; Dexamethasone; Calcium Dobesilate

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Rachid Baz, MD
• Organization: Moffitt Cancer Center

Rachid.Baz@moffitt.org

813-745-3163

Study Officials

• Rachid Baz, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: January 14, 2010
• Primary Completion: August 1, 2020
• Study Completion: November 24, 2020
• Last Updated: October 13, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-10

Locations

US (1)