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

NCT00966693 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 2009-0179NCI-2018-01857P30CA016672
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

  To determine the dose limitations toxicities of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM).

  After one 28-day cycle

• Complete Response(CR) and Very Good Partial Response(VGPR)

  To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir.

  Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).

Secondary Outcomes (5)

• Time to Progression

  Up to 9 years

• Progression Free Survival

  Up to 9 years

• Time to Best Response

  Up to 9 years

• Incidence of Adverse Events

  Up to 9 years

• Time to Next Therapy

  Up to 4.5 years

Study Arms (1)

Treatment (lenalidomide, thalidomide, dexamethasone)

EXPERIMENTAL

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; Drug: Lenalidomide; Drug: Thalidomide

Interventions

Dexamethasone DRUG

Given PO

Also known as: 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

Treatment (lenalidomide, thalidomide, dexamethasone)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (lenalidomide, thalidomide, dexamethasone)

Thalidomide DRUG

Given PO

Also known as: (+)-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

Treatment (lenalidomide, thalidomide, dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Lenalidomide; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

No pharmaco-dynamic marker to support an effect of signaling downregulation in lenalidomide-refractory patients to corroborate low dose thalidomide (50-100 mg) with or without dexamethasone has a therapeutic benefit with lenalidomide.

Results Point of Contact

• Title: Weber,Donna M.,M.D. / Lymphoma/Myeloma
• Organization: UT MD Anderson Cancer Center

dmweber@mdanderson.org

713-792-2860

Study Officials

• Donna Weber

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: August 25, 2009
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Locations

US (1)