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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054144
Recruitment Status : Active, not recruiting
First Posted : January 22, 2010
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Prednisone Drug: Dexamethasone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 14, 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Combined Therapy - Number of Participants With Progression Free Survival (PFS) [ Time Frame: 12 Months ]
    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 :
  1. Number of Participants With Desired Response [ Time Frame: First measure at 8 weeks ]
    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

  2. Number of Participants With Adverse Events [ Time Frame: First measure at 8 weeks ]
    The toxicity profile of these lenalidomide based combinations

  3. Single Agent - Number of Participants With Progressive Free Survival (PFS) [ Time Frame: First measure at 8 weeks ]
    The progression free survival of patients treated with single agent lenalidomide

  4. Number of Participants With 1 Year Overall Survival (OS) [ Time Frame: 1 Year ]
    The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054144

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
Principal Investigator: Rachid Baz, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT01054144     History of Changes
Other Study ID Numbers: MCC-16018
108562 ( Other Identifier: USF IRB )
RV-MM-PI-0454 ( Other Grant/Funding Number: Celgene )
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal