Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2024-07-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase II trial studies the effect of immunomodulatory drug(s) in combination with a corticosteroid drug in treating patients with multiple myeloma or smoldering multiple myeloma. Immunomodulatory drugs such as lenalidomide and pomalidomide work through a variety of mechanisms to affect the function of the immune system. They are widely used as treatment for multiple myeloma and remain the backbone of therapy for both newly diagnosed patients and patients that have multiple myeloma that has come back after treatment (relapsed). Corticosteroid drugs like dexamethasone are strong anti-inflammatory agents that are also widely used to treat patients with multiple myeloma. This study may help doctors find out how patients respond to one treatment cycle of immunomodulatory drug(s) in combination with dexamethasone. This may help doctors determine which combinations of drugs work best in treating patients with multiple myeloma or smoldering multiple myeloma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant

NCT02880228

Plasma Cell Myeloma

COMPLETED PHASE2

Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide

NCT01794039

Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma

COMPLETED PHASE2

Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma

NCT03713294

Refractory Plasma Cell Myeloma

COMPLETED PHASE2

Ibrutinib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Ineligible for Transplant

NCT03015792

Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma

TERMINATED PHASE1

Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT01212952

Refractory Multiple Myeloma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVE:

I. To determine response rates (\>= partial response \[PR\]) of prospectively treated multiple myeloma (MM) patients with one cycle of therapy containing a combination of an immunomodulator and dexamethasone.

SECONDARY OBJECTIVE:

I. To identify biomarkers that predict response rates of untreated smoldering MM and MM patients to a combination of an immunomodulator and dexamethasone.

II. To compare response rates of MM among African-Americans (AA) and white patients to a combination of an immunomodulator and dexamethasone.

III. To establish correlation of biomarkers in treated MM patients with the combination of an immunomodulator and dexamethasone to the depth of hematological response observed in new or previously treated patients

OUTLINE: Patients are assigned to 1 of 4 cohorts.

COHORT A: Patients with smoldering multiple myeloma receive lenalidomide orally (PO) once daily (QD) alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

COHORT B: Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.

COHORT C: Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

COHORT D: Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.

After completion of study treatment, patients are followed up within 7 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plasma Cell Myeloma Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma Smoldering Plasma Cell Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A (lenalidomide, dexamethasone)

Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Bone Marrow Biopsy

Intervention Type PROCEDURE

Undergo bone marrow aspirate/biopsy

Dexamethasone

Intervention Type DRUG

Given orally

Lenalidomide

Intervention Type DRUG

Given orally

Cohort B (lenalidomide, dexamethasone)

Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A.

Group Type EXPERIMENTAL

Bone Marrow Biopsy

Intervention Type PROCEDURE

Undergo bone marrow aspirate/biopsy

Dexamethasone

Intervention Type DRUG

Given orally

Lenalidomide

Intervention Type DRUG

Given orally

Cohort C (lenalidomide, dexamethasone, pomalidomide)

Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Bone Marrow Biopsy

Intervention Type PROCEDURE

Undergo bone marrow aspirate/biopsy

Dexamethasone

Intervention Type DRUG

Given orally

Lenalidomide

Intervention Type DRUG

Given orally

Pomalidomide

Intervention Type DRUG

Given orally

Cohort D (lenalidomide, dexamethasone, pomalidomide)

Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C.

Group Type EXPERIMENTAL

Bone Marrow Biopsy

Intervention Type PROCEDURE

Undergo bone marrow aspirate/biopsy

Dexamethasone

Intervention Type DRUG

Given orally

Lenalidomide

Intervention Type DRUG

Given orally

Pomalidomide

Intervention Type DRUG

Given orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bone Marrow Biopsy

Undergo bone marrow aspirate/biopsy

Intervention Type PROCEDURE

Dexamethasone

Given orally

Intervention Type DRUG

Lenalidomide

Given orally

Intervention Type DRUG

Pomalidomide

Given orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biopsy of Bone Marrow Biopsy, Bone Marrow Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycadron Baycuten Baycuten N Cortidexason Cortisumman Decacort Decadrol Decadron Decadron DP 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 Dexamethasone Intensol Dexamethasonum Dexamonozon Dexapos Dexinoral Dexone Dinormon Dxevo Fluorodelta Fortecortin Gammacorten Hemady Hexadecadrol Hexadrol Lokalison-F Loverine Methylfluorprednisolone Millicorten Mymethasone Orgadrone Spersadex TaperDex Visumetazone ZoDex CC-5013 CC5013 CDC 501 Revlimid 4-Aminothalidomide Actimid CC-4047 Imnovid Pomalyst

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \>= 18 years
* COHORT A: Patient must have untreated smoldering multiple myeloma which is defined by the presence of 10% or more but less than 60% clonal plasma cells in the bone marrow and the absence of any of the following myeloma related symptoms or laboratory and radiographic abnormalities: anemia, hypercalcemia, renal insufficiency, hypercalcemia, serum free light chain ratio of greater than 100 or more than one focal marrow multiple myeloma lesion on magnetic resonance imaging (MRI)
* COHORT B: Patient must have newly diagnosed myeloma requiring treatment and no prior therapies
* COHORT C: Patient must have relapsed or refractory multiple myeloma with at least one prior therapy for their multiple myeloma but not refractory to all IMiDs
* COHORT D: Patient must have relapsed or refractory multiple myeloma with lenalidomide as part of a maintenance regimen as their most recent therapy
* Measurable disease
* Provide written informed consent
* Patient must be considered for treatment with an IMiD containing regimen
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
* Hemoglobin \>= 9.0 g/dL (obtained =\< 14 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
* Platelet count \>= 100,000/mm\^3 (obtained =\< 14 days prior to registration)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome, in which case the direct bilirubin must be =\< 1.5 X ULN (obtained =\< 14 days prior to registration)
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 14 days prior to registration)
* Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =\< 14 days prior to registration)
* Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
* Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only

* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
* Willingness to provide mandatory blood and bone marrow specimens for correlative research
* Willing to follow the requirements of the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) program

Exclusion Criteria

* An agent that has known genotoxic, mutagenic and teratogenic effects:

* Pregnant persons
* Nursing persons
* Persons of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* History of myocardial infarction =\< 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No