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Trial record 82 of 370 for:    LENALIDOMIDE AND Dexamethasone

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed 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: NCT01049945
Recruitment Status : Unknown
Verified April 2016 by Mayo Clinic.
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2010
Results First Posted : March 30, 2015
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving bendamustine hydrochloride together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride and lenalidomide when given together with dexamethasone and to see how well they work in treating patients with relapsed multiple myeloma.

Condition or disease Intervention/treatment Phase
Refractory Multiple Myeloma Drug: bendamustine hydrochloride Drug: lenalidomide Drug: dexamethasone Phase 1 Phase 2

Detailed Description:
PRIMARY OBJECTIVES: I. To determine the Maximum Tolerated Dose (MTD) of bendamustine and lenalidomide in combination with dexamethasone in subjects with Multiple Myeloma (MM) in first or second relapse. (Phase I) II. To evaluate the confirmed response rate of bendamustine in combination with lenalidomide and dexamethasone in subjects with MM in first or second relapse. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the safety of bendamustine in combination with lenalidomide and dexamethasone. (Phase I and II) II. To evaluate time-to-tumor-progression, progression-free survival, duration of response, and overall survival. (Phase II) OUTLINE: This is a phase I dose escalation study of bendamustine hydrochloride and lenalidomide followed by a phase II study. Patients receive dexamethasone orally or IV on days 1, 8, 15, and 22; bendamustine hydrochloride IV over 30 minutes on days 1 and 2; and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least stable disease after 6 courses may continue to receive lenalidomide and dexamethasone as above in the absence of disease progression or unacceptable toxicity. Dexamethasone may be discontinued after 12 courses of therapy at the treating investigator's discretion. After completion of study treatment, patients are followed at 4 weeks and then periodically for up to 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Multicenter, Open-label, Dose-escalation Study of Bendamustine in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma
Study Start Date : February 2010
Actual Primary Completion Date : November 2012

Arm Intervention/treatment
Experimental: Arm I
Patients receive dexamethasone orally or IV on days 1, 8, 15, and 22; bendamustine hydrochloride IV over 30 minutes on days 1 and 2; and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: bendamustine hydrochloride
Given IV
Other Names:
  • bendamustin hydrochloride
  • bendamustine
  • cytostasan hydrochloride
  • Ribomustin
  • SDX-105
  • Treanda

Drug: lenalidomide
Given orally
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid

Drug: dexamethasone
Given orally or IV
Other Names:
  • Aeroseb-Dex
  • Decaderm
  • Decadron
  • Decaspray
  • DM
  • DXM

Primary Outcome Measures :
  1. Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I) [ Time Frame: One cycle of treatment ]

    The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:

    • Grade 2 neuropathy with pain
    • Any grade 3 Non-Hematologic toxicity
    • Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.
    • Grade 4 neutropenia
    • Febrile neutropenia
    • Grade 4 thrombocytopenia
    • Grade 3 thrombocytopenia associated with bleeding
    • Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.

    We are reporting the results of this endpoint as the number of DLTs per dose level.

  2. Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR). [ Time Frame: Up to 6 cycles of treatment ]

    Complete response (CR)

    - Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.

    Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow

    Near complete response (nCR) A CR, with the persistence of original monoclonal protein

    Very good partial response (VGPR)

    - Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h

    Partial response (PR)

    • ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.
    • a ≥50% decrease in the difference between involved and uninvolved FLC levels
    • or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline.

Secondary Outcome Measures :
  1. Duration of Response (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
  2. Time to Progression (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
  3. Progression Free Survival (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]
  4. Overall Survival (Phase II) [ Time Frame: Up to 2 years from study completion (6 years total) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of MM and documentation of at least 1 prior therapy (induction therapy followed by stem cell transplantation is considered one prior therapy) but not more than two previous therapies
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA or at high risk of developing thrombosis may use warfarin or low molecular weight heparin)
  • AST (SGOT) and ALT (SGPT) =< 3.0 x upper limit of normal (ULN)
  • Creatinine clearance >= 60 mL/min (Cockcroft-Gault calculation) for patients enrolled in Phase 1 and Creatinine clearance >= 30 mL/min (Cockcroft-Gault calculation) for patients enrolled in phase 2 portion
  • Patients with measurable disease, defined by any of the following: serum monoclonal protein >= 1.0 g by protein electrophoresis; > 200 mg of monoclonal protein in the urine on 24-hour electrophoresis; serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio; or monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
  • All necessary baseline studies for determining eligibility must be obtained within 21 days prior to enrollment
  • Subject has an ECOG =< 2 OR Karnofsky >= 60% performance status; patients with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible
  • FCBP 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 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing
  • Absolute neutrophil count (ANC) >= 1,000 cells/dL (1.0 x 10^9/L) (growth factors cannot be used within 14 days of first drug administration)
  • Untransfused platelet count >= 75,000 cells/dL (50 x 10^9/L) for patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count >=50,000/dL for patients in whom 50% of bone marrow nucleated cells are plasma cells
  • Total Bilirubin =< 1.5 mg/dL
  • Hemoglobin >= 8.0 g/dl


  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
  • Patients may be receiving concomitant therapy with bisphosphonates and low dose corticosteroids (e.g., prednisone up to but no more than 10 mg p.o. q.d. or its equivalent) for symptom management and comorbid conditions; doses of corticosteroid should be stable for at least 7 days prior to study treatment
  • Prior radiation therapy within 2 weeks of the first dose of study treatment
  • Known active infection requiring parenteral or oral anti-infective treatment
  • Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation
  • Patient has hypersensitivity to any of the components of study therapy - Known HIV or active hepatitis B or C viral infection
  • Known hypersensitivity to required prophylactic medications
  • Patient has received other investigational drugs within 14 days before enrollment
  • Pregnant or breast-feeding females (lactating females must agree not to breast feed while taking lenalidomide)
  • Subjects with evidence of mucosal or internal bleeding and/or platelet transfusion refractory (i.e., unable to maintain a platelet count >= 50,000 cells/mm^3)
  • Concurrent therapy with a marketed or investigational anticancer therapy
  • Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
  • Other investigational agents are not to be used during the study
  • Prior peripheral stem cell transplant within 12 weeks of the first dose of study treatment

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): NCT01049945

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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 55904
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington Universtiy School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Mayo Clinic
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Study Chair: Shaji K. Kumar, M.D. Mayo Clinic
Principal Investigator: Vivek Roy, M.D. Mayo Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mayo Clinic Identifier: NCT01049945     History of Changes
Other Study ID Numbers: MMRC-020-021
NCI-2009-01535 ( Registry Identifier: NCI's CTRO )
MMRC-020-021 ( Other Identifier: Mayo Clinic Cancer Center & MMRC )
09-004211 ( Other Identifier: Mayo Clinic IRB )
C18083/6125 ( Other Identifier: Cephalon protocol )
First Posted: January 15, 2010    Key Record Dates
Results First Posted: March 30, 2015
Last Update Posted: May 27, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Dexamethasone acetate
BB 1101
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
Bendamustine Hydrochloride
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents