Lenalidomide, Thalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: August 26, 2009
Last updated: November 30, 2015
Last verified: November 2015

The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of thalidomide, lenalidomide, and dexamethasone that can be given to patients with relapsed or refractory MM.

The goal of the Phase II portion of this study is to learn if the drug combination can help to control the disease.

The safety of the drug combination will be studied in both phases.

Condition Intervention Phase
Drug: Lenalidomide
Drug: Thalidomide
Drug: Dexamethasone
Phase 1
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 I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Combination of Lenalidomide, Thalidomide and Dexamethasone in Multiple Myeloma Participants [ Time Frame: End of Cycle 1 (28 Days) ] [ Designated as safety issue: Yes ]
    MTD of the combination of lenalidomide, thalidomide and dexamethasone in multiple myeloma subjects defined at the end of the trial, the dose with the smallest absolute value of (posterior mean of pi-pT) among all the tried doses i for which Ti=0 selected as the MTD.

Estimated Enrollment: 64
Study Start Date: August 2009
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + Thalidomide + Dexamethasone
Lenalidomide 15 mg daily by mouth on Days 1-21 followed by 7-day rest every 28 day cycle for Cycles 1-8. Thalidomide 100 mg daily by mouth on Days 1-28 of Cycles 1-8. Dexamethasone 40 mg by mouth on Days 1-4, 9-12, and 17-20 of Cycles 1-2, and 40 mg by mouth on Days 1, 8, 15, and 21 of Cycles 3-8.
Drug: Lenalidomide
Starting dose:15 mg daily by mouth on Days 1-21 followed by 7-day rest every 28 day cycle for Cycles 1-8
Other Names:
  • Revlimid
  • CC-5013
Drug: Thalidomide
Starting dose:100 mg daily by mouth on Days 1-28 of Cycles 1-8
Other Name: Thalomid
Drug: Dexamethasone

40 mg by mouth on Days 1-4, 9-12, and 17-20 of Cycles 1-2.

40 mg by mouth on Days 1, 8, 15, and 21 of Cycles 3-8.

Other Name: Decadron

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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age >/= 18 years at the time of signing the informed consent form.
  3. Relapsed/refractory MMM with measurable levels of myeloma paraprotein in serum ( >/= 0.5 g/dl), urine ( >/= 0.2 g excreted in a 24-hour collection sample), or abnormal free light chain (FLC) ratio.
  4. Serum Creatinine </= 2.5 mg/dl
  5. Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide 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 affective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
  6. Continuation from Inclusion # 6: FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of childbearing potential 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.
  7. Continuation from Inclusion # 7: * A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  8. Laboratory test results within these ranges: Absolute neutrophil count > 1000 cells/mm^3 Platelet count > 50,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells and platelet count > 25,000 cells/mm^3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells Total bilirubin </= 2.0 mg/dL AST (SGOT) and ALT (AGPT) < 3 x ULN
  9. Able to take prophylactic anticoagulation, warfarin or equivalent agent
  10. Patient is able to understand and comply with the terms and conditions of the Lenalidomide and Thalidomide Counseling Program
  11. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®, AND the S.T.E.P.S.® program.

Exclusion Criteria:

  1. Any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form
  2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  3. Use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy (radiation therapy allowed within 5 days of completion of radiation therapy).
  4. Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.
  5. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00966693

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Study Chair: Jatin J. Shah, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00966693     History of Changes
Other Study ID Numbers: 2009-0179  NCI-2009-01622 
Study First Received: August 26, 2009
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Relapsed/Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2016