Lenalidomide, Thalidomide and Dexamethasone in Relapsed/Refractory 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: NCT00966693
Recruitment Status : Active, not recruiting
First Posted : August 27, 2009
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Myeloma Drug: Lenalidomide Drug: Thalidomide Drug: Dexamethasone Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : August 2009
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Combination of Lenalidomide, Thalidomide and Dexamethasone in Multiple Myeloma Participants [ Time Frame: End of Cycle 1 (28 Days) ]
    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.

Secondary Outcome Measures :
  1. Overall Response of Combination of Lenalidomide, Thalidomide and Dexamethasone in Multiple Myeloma Participants [ Time Frame: End of 4 Cycles (112 Days) ]
    Overall response monitored using the Bayesian approach of Thall, Simon, Estey (1995, 1996) as extended by Thall and Sung (1998).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00966693

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Donna M. Weber, MD, BS M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00966693     History of Changes
Other Study ID Numbers: 2009-0179
NCI-2009-01622 ( Registry Identifier: NCI CTRP )
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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
Antineoplastic Agents