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Trial record 80 of 371 for:    LENALIDOMIDE AND Dexamethasone

Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00966693
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase I/II trial studies the best dose and side effects of lenalidomide and thalidomide, and how well they work with dexamethasone in treating participants with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, thalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Condition or disease Intervention/treatment Phase
Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Drug: Dexamethasone Drug: Lenalidomide Drug: Thalidomide Phase 1 Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM). (Phase 1) II. To determine the overall (complete remission [CR)]+ very good partial response [VGPR]+ partial response [PR)] response rate of the combination after 4 cycles of therapy. (Phase 2)

SECONDARY OBJECTIVES:

I. To determine the overall response rate (ORR). (Phase 1) II. To determine the time to progression (TTP). (Phase 1) III. To determine the progression free survival (PFS). (Phase 1) IV. To determine the time to best response. (Phase 1) V. To determine the CR, VGPR. (Phase 2) VI. To determine the time to progression (TTP). (Phase 2) VII. To determine the progression free survival (PFS). (Phase 2) VIII. To determine the time to best response. (Phase 2) IX. To assess the safety of the combination of LTD in patients with RRMM. (Phase 2) X. Time to next therapy. (Phase 2) XI. Symptom measurement - multiple-symptom assessment tool. (Phase 2)

OUTLINE: This is a dose-escalation study of lenalidomide and thalidomide.

Participants receive lenalidomide orally (PO) on days 1-21 and thalidomide PO once daily (QD) on days 1-28. Participants also receive dexamethasone PO QD on days 1-4, 9-12, and 17-20 of courses 1-2, and days 1, 8, 15, and 22 of subsequent courses. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Participants who have stable or responding disease to treatment receive lenalidomide PO on days 1-21 and thalidomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants may receive dexamethasone at the discretion of the investigator.

After completion of study treatment, patients are followed up at 30 days.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 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 25, 2009
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018


Arm Intervention/treatment
Experimental: Treatment (lenalidomide, thalidomide, dexamethasone)

Participants receive lenalidomide PO on days 1-21 and thalidomide PO QD on days 1-28. Participants also receive dexamethasone PO QD on days 1-4, 9-12, and 17-20 of courses 1-2, and days 1, 8, 15, and 22 of subsequent courses. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Participants who have stable or responding disease to treatment receive lenalidomide PO on days 1-21 and thalidomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants may receive dexamethasone at the discretion of the investigator.

Drug: Dexamethasone
Given PO
Other Names:
  • Aacidexam
  • Adexone
  • Aknichthol Dexa
  • Alba-Dex
  • Alin
  • Alin Depot
  • Alin Oftalmico
  • Amplidermis
  • Anemul mono
  • Auricularum
  • Auxiloson
  • Baycuten
  • Baycuten N
  • Cortidexason
  • Cortisumman
  • Decacort
  • Decadrol
  • Decadron
  • Decalix
  • Decameth
  • Decasone R.p.
  • Dectancyl
  • Dekacort
  • Deltafluorene
  • Deronil
  • Desamethasone
  • Desameton
  • Dexa-Mamallet
  • Dexa-Rhinosan
  • Dexa-Scheroson
  • Dexa-sine
  • Dexacortal
  • Dexacortin
  • Dexafarma
  • Dexafluorene
  • Dexalocal
  • Dexamecortin
  • Dexameth
  • Dexamethasonum
  • Dexamonozon
  • Dexapos
  • Dexinoral
  • Dexone
  • Dinormon
  • Fluorodelta
  • Fortecortin
  • Gammacorten
  • Hexadecadrol
  • Hexadrol
  • Lokalison-F
  • Loverine
  • Methylfluorprednisolone
  • Millicorten
  • Mymethasone
  • Orgadrone
  • Spersadex
  • Visumetazone

Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid

Drug: Thalidomide
Given PO
Other Names:
  • (+)-Thalidomide
  • (-)-Thalidomide
  • .alpha.-Phthalimidoglutarimide
  • 2, 6-Dioxo-3-phthalimidopiperidine
  • Alpha-Phthalimidoglutarimide
  • Contergan
  • Distaval
  • Kevadon
  • N-(2,6-Dioxo-3-piperidyl)phthalimide
  • N-Phthaloylglutamimide
  • N-Phthalylglutamic Acid Imide
  • Neurosedyn
  • Pantosediv
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (+)-
  • Phthalimide, N-(2, 6-dioxo-3-piperidyl)-, (-)-
  • Sedalis
  • Sedoval K-17
  • Softenon
  • Synovir
  • Talimol
  • Thalomid




Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Up to 28 days ]
  2. Complete response and very good partial response [ Time Frame: Up to 9 years ]
    Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 9 years ]
    Logistic regression will be utilized to assess the effect of patient prognostic factors on the response rate.

  2. Time to progression [ Time Frame: Up to 9 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.

  3. Progression free survival [ Time Frame: Up to 9 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.

  4. Time to best response [ Time Frame: Up to 9 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.

  5. Incidence of adverse events [ Time Frame: Up to 9 years ]
    Logistic regression will be utilized to assess the effect of patient prognostic factors on the toxicity rate.

  6. Time to next therapy [ Time Frame: Up to 9 years ]
    Will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.



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
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form
  • Relapsed/refractory multiple myeloma (MM) 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
  • Serum creatinine =< 2.5 mg/dl
  • 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 effective method AT THE SAME TIME, at least 28 days before she starts 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 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.

    • 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).
  • 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
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 3 x upper limit of normal (ULN)
  • Able to take prophylactic anticoagulation, warfarin or equivalent agent
  • Patient is able to understand and comply with the terms and conditions of the lenalidomide and thalidomide counseling program
  • 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:

  • Any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
  • 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).
  • Known hypersensitivity to thalidomide, lenalidomide and dexamethasone.
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00966693


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Donna Weber M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00966693     History of Changes
Other Study ID Numbers: 2009-0179
NCI-2018-01857 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2009-0179 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
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
Thalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents