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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01054144
First received: January 21, 2010
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide
Drug: Prednisone
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Combined Therapy - Number of Participants With Progression Free Survival (PFS) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    The 12-month 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 Outcome Measures:
  • Number of Participants With Desired Response [ Time Frame: First measure at 8 weeks ] [ Designated as safety issue: No ]
    The response rate of older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy

  • Number of Participants With Adverse Events [ Time Frame: First measure at 8 weeks ] [ Designated as safety issue: Yes ]
    The toxicity profile of these lenalidomide based combinations

  • Single Agent - Number of Participants With Progressive Free Survival (PFS) [ Time Frame: First measure at 8 weeks ] [ Designated as safety issue: No ]
    The progression free survival of patients treated with single agent lenalidomide

  • Number of Participants With 1 Year Overall Survival (OS) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach


Estimated Enrollment: 70
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Response Adapted Therapy
Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.
Drug: Lenalidomide
  • 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
Other Name: Revlimid®
Drug: Prednisone
  • 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
Drug: Dexamethasone
  • 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
Other Name: Decadron

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.

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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054144

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Celgene Corporation
Investigators
Principal Investigator: Rachid Baz, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01054144     History of Changes
Other Study ID Numbers: MCC-16018, 108562, RV-MM-PI-0454
Study First Received: January 21, 2010
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Newly Diagnosed Standard Risk Multiple Myeloma
Senior Adults

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 26, 2014