Pomalidomide

Acquired Immunodeficiency Syndrome, HIV Vaccine, Multiple Myeloma + 2 more

Treatment

4 FDA approvals

20 Active Studies for Pomalidomide

What is Pomalidomide

Pomalidomide

The Generic name of this drug

Treatment Summary

Pomalidomide is a medication that works to treat cancer by changing how the immune system works. It is similar to thalidomide and was approved by the FDA in 2013.

Pomalyst

is the brand name

image of different drug pills on a surface

Pomalidomide Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Pomalyst

Pomalidomide

2013

4

Approved as Treatment by the FDA

Pomalidomide, otherwise known as Pomalyst, is approved by the FDA for 4 uses including Multiple Myeloma (MM) and Trialled at least two prior therapies including lenalidomide and a proteasome inhibitor .

Multiple Myeloma (MM)

Used to treat Multiple Myeloma (MM) in combination with Dexamethasone

Trialled at least two prior therapies including lenalidomide and a proteasome inhibitor

Used to treat Trialled at least two prior therapies including lenalidomide and a proteasome inhibitor in combination with Dexamethasone

Multiple Myeloma

Used to treat Trialled at least two prior therapies including lenalidomide and a proteasome inhibitor in combination with Dexamethasone

Multiple Myeloma

Used to treat Multiple Myeloma (MM) in combination with Dexamethasone

Effectiveness

How Pomalidomide Affects Patients

Pomalidomide is much stronger than the drugs thalidomide and lenalidomide, being 100 times more potent than thalidomide and 10 times more potent than lenalidomide.

How Pomalidomide works in the body

Promalidomide modifies the immune system to fight cancer. It stops the growth and reproduction of tumor cells, and increases the ability of T cells and natural killer cells to fight cancer. It also reduces inflammation by preventing the production of certain proteins. The primary way it works is by binding to a protein called cereblon and blocking its ability to produce certain molecules. It also stops the production of a molecule involved in inflammation.

When to interrupt dosage

The amount of Pomalidomide is contingent upon the identified illness. The amount of dosage is contingent upon the technique of delivery (e.g. Oral or Capsule) recorded in the table beneath.

Condition

Dosage

Administration

Multiple Myeloma

, 1.0 mg, 2.0 mg, 3.0 mg, 4.0 mg

, Capsule, Oral, Capsule - Oral

HIV Vaccine

, 1.0 mg, 2.0 mg, 3.0 mg, 4.0 mg

, Capsule, Oral, Capsule - Oral

Acquired Immunodeficiency Syndrome

, 1.0 mg, 2.0 mg, 3.0 mg, 4.0 mg

, Capsule, Oral, Capsule - Oral

Kaposi Sarcoma

, 1.0 mg, 2.0 mg, 3.0 mg, 4.0 mg

, Capsule, Oral, Capsule - Oral

Multiple Myeloma

, 1.0 mg, 2.0 mg, 3.0 mg, 4.0 mg

, Capsule, Oral, Capsule - Oral

Warnings

There are 20 known major drug interactions with Pomalidomide.

Common Pomalidomide Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Pomalidomide is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Acteoside

Major

The risk or severity of adverse effects can be increased when Pomalidomide is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Pomalidomide is combined with Antilymphocyte immunoglobulin (horse).

Azelastine

Major

Pomalidomide may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Bacillus calmette-guerin substrain russian BCG-I live antigen

Major

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Pomalidomide.

Pomalidomide Toxicity & Overdose Risk

Common side effects of this drug include tiredness, low levels of white blood cells, anemia, constipation, nausea, diarrhea, shortness of breath, upper respiratory infections, back pain, and fever.

image of a doctor in a lab doing drug, clinical research

Pomalidomide Novel Uses: Which Conditions Have a Clinical Trial Featuring Pomalidomide?

17 active investigations are underway to assess the potential of Pomalidomide in providing relief from Refractory Multiple Myeloma.

Condition

Clinical Trials

Trial Phases

Kaposi Sarcoma

7 Actively Recruiting

Phase 1, Phase 2

Multiple Myeloma

6 Actively Recruiting

Phase 1, Phase 2

Multiple Myeloma

0 Actively Recruiting

HIV Vaccine

0 Actively Recruiting

Acquired Immunodeficiency Syndrome

4 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Pomalidomide Reviews: What are patients saying about Pomalidomide?

5

Patient Review

1/22/2016

Pomalidomide for Multiple Myeloma

This treatment is effective with minimal side effects.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about pomalidomide

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is pomalidomide a chemotherapy?

"The trade name for the drug Pomalyst is Pomalidomide. Health care professionals may use either the trade name or the generic name when referring to the drug."

Answered by AI

What is pomalidomide used for?

"Pomalidomide is a cancer medicine used to treat AIDS-related Kaposi sarcoma in patients who have received highly active antiretroviral therapy (HAART) that did not work well, or Kaposi sarcoma in patients who do not have HIV infection (HIV-negative)."

Answered by AI

What class of drug is pomalidomide?

"Pomalidomide is an immunomodulatory drug that helps the bone marrow produce normal blood cells and kills abnormal cells in the bone marrow."

Answered by AI

Is pomalidomide better than lenalidomide?

"Pomalidomide is felt to be the most potent immunomodulatory drug (IMiD): 100 times the strength of thalidomide and 10 times that of lenalidomide [Gertz, 2013]. Cereblon expression by gene expression profiling was recently evaluated in 53 patients with relapsed/refractory myeloma treated with pomalidomide and dexamethasone [Schuster et al. 2012]."

Answered by AI

Clinical Trials for Pomalidomide

Image of New Jersey Community Research Initiative in Newark, United States.

AI-DBT for Suicide Prevention in HIV/AIDS

18+
All Sexes
Newark, NJ

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Recruiting
Has No Placebo

New Jersey Community Research Initiative (+1 Sites)

Elissa Kozlov, PhD

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CYT107 for Kaposi's Sarcoma

18 - 120
All Sexes
Bethesda, MD

Background: Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Having HIV can weaken the immune system and this can lead to KS. Weaker immune systems may be measured by low T cells (a type of immune cell). CYT107 is a human protein, made in a laboratory, that may help boost immunity, specifically by increasing T cells, in people with HIV-associated KS. Objective: To see if CYT107 can shrink KS tumors. Eligibility: People aged 18 years and older with HIV-associated KS. Design: Participants will be screened. They will have a physical exam with blood tests. Their skin lesions will be measured. They will have an x-ray of their lungs. Their ability to perform everyday tasks will be reviewed. A sample of lesion tissue (biopsy) may be collected from the skin. CYT107 is injected into the muscle of the arm, buttocks, or lower thigh once a week for up to 4 weeks. Participants will receive the shots at the clinic. Blood and other tests will be repeated at each visit. KS lesions will be measured and photographed on the 1st and 4th visits. Participants who improved after the first 4 weeks may have another 4-week treatment within a year. Follow-up visits will continue for 3 years.

Phase 2
Waitlist Available

National Institutes of Health Clinical Center

Ramya M Ramaswami, M.D.

Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA

This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center

Hayoun Lee, PhD

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Propranolol for Kaposi Sarcoma

18+
All Sexes
Minneapolis, MN

Kaposi sarcoma (KS) lesions are initiated by endothelial cells infected with KS herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). Lesion progression is driven by abnormal angiogenesis, chronic inflammation, and uncontrolled cell proliferation. KS remains one of the most commonly diagnosed cancers in many African countries where economic constraints prevent successful treatment in most patients. Treatment outcomes in developed countries are also often unsatisfactory in HIV positive patients despite good virological and immunological responses to antiretroviral therapy. Therefore, identification of new oral, safe treatment options for treatment of KS remains a research priority. Given the known anti-angiogenic properties and based on the treatment response with other benign vascular lesions such as infantile hemangioma, propranolol is a good candidate for the treatment of KS. The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate plus partial response rate) of at least 45%, and that propranolol will be safe and well tolerated in this patient population.

Phase 2
Recruiting

University of Minnesota (+3 Sites)

Lee Ratner, M.D., Ph.D.

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Limited-duration Teclistamab for Multiple Myeloma

18+
All Sexes
Philadelphia, PA

This is a single-arm, non-inferiority study in which patients who have achieved a very good partial response (VGPR) or better, according to International Myeloma Working Group (IMWG) response criteria, following 6 to 9 months of treatment with teclistamab, a B-cell maturation antigen (BCMA)-directed T-cell engager (anti-BCMAxCD3 bispecific antibody), will be offered monitored drug discontinuation. Teclistamab is typically dosed on a regular schedule (every 1-4 weeks) indefinitely until disease progression ("continuous therapy"). Here, a limited-duration regimen will be studied in which patients achieving ≥VGPR after 6-9 months of standard teclistamab dosing will discontinue therapy and resume if laboratory or clinical parameters suggest early disease progression ("limited-duration therapy"). Patients will enter the clinical trial protocol after completing 6-9 months of standard teclistamab monotherapy and achieving ≥VGPR. The study's hypothesis is that the failure probability six months after stopping teclistamab in this patient population will be non-inferior compared to that of historical controls treated with continuous therapy. Reducing drug exposure may be beneficial by reducing risk of infection and reducing anti-BCMA selective pressure toward generation of BCMA-negative relapses. Analysis of minimal residual disease (MRD), tumor features, and bone marrow microenvironment parameters, which will be pursued as exploratory correlative analyses in this study, may identify factors that predict durable response to limited-duration therapy and thereby enable more precise selection of patients likely to benefit from this approach. A subset of patients will be enrolled on a biomarker study for analysis of these exploratory endpoints.

Phase 2
Recruiting

Abramson Cancer Center at University of Pennsylvania (+4 Sites)

Alfred Garfall, MD

Image of Columbia University Irving Medical Center in New York, United States.

WiseApp for HIV

18+
All Sexes
New York, NY

This study aims to conduct a 12-month randomized controlled trial to adapt the mobile app, WiseApp, and a smart pill dispenser for Spanish-speaking people living with HIV (PLWH) in the New York City (NYC) area and La Romana, Dominican Republic (DR). The study will assess the efficacy and sustainability of WiseApp as well as identify barriers with its widespread use among Spanish speakers. With disproportionately high rates of HIV in the New York City area and the Dominican Republic, this project seeks to identify distinct contextual factors related to Spanish speaking people living with HIV and increase the likelihood of engagement with technology and improvements in clinical outcomes.

Recruiting
Has No Placebo

Columbia University Irving Medical Center

Rebecca Schnall, PhD, MPH

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Abemaciclib for Kaposi Sarcoma

18+
All Sexes
Bethesda, MD

Background: Kaposi Sarcoma (KS) is common in people with human immunodeficiency virus (HIV) but can also occur in people who do not have HIV. KS tumors usually involve the skin, but may also involve lymph nodes, lungs, bone, and gastrointestinal tract. Researchers want to see if a drug that is currently used to treat a type of breast cancer can help. Objective: To find a safe dose of abemaciclib to treat KS and to see if it can shrink lesions or tumors. Eligibility: People ages 18 and older with KS. Design: Participants will be screened with some or all of the following: Medical history Physical exam Blood and urine tests Chest x-ray and/or computed tomography scans Lung or gastrointestinal tract exam with an endoscope (a flexible instrument to examine the interior of the organ) Medicine review Heart function tests KS lesion assessment Skin sample from a KS lesion Treatment will be given in 28-day cycles. Participants will take the study drug tablets by mouth everyday. They will keep a medicine diary. They will get the study drug until their cancer gets worse or they have unacceptable side effects. Participants will have a study visit at the beginning of each cycle. At these visits, they will repeat some screening tests. They may have medical photographs taken of body surfaces. They may complete questionnaires about their quality of life. They may give skin and saliva samples. For skin samples, an area of skin will be numbed. A small circle of skin over an area affected by KS will be removed. Participants will have follow-up visits for up to 2 years after treatment ends.

Phase 1 & 2
Recruiting

National Institutes of Health Clinical Center

Ramya M Ramaswami, M.D.

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Pomalidomide + Nivolumab for Viral Associated Cancers

18 - 99
All Sexes
Bethesda, MD

Background: Less toxic and more effective treatments are needed for cancers caused by viruses. These cancers include Hodgkin and non-Hodgkin lymphoma, hepatocellular carcinoma, head and neck cancer, nasopharyngeal carcinoma, gastric cancer, anal cancer, cervical cancer, vaginal cancer, vulvar cancer, penile cancer, Merkel cell carcinoma, Kaposi sarcoma, and leiomyosarcoma. Researchers want to see if a combination of drugs can help. Objective: To find a safe dose of pomalidomide plus nivolumab in people with cancers caused by viruses. Eligibility: Adults ages 18 or older who have cancers caused by Epstein Barr virus (EBV), human herpes virus 8/Kaposi sarcoma herpesvirus (HHV8/KSHV), human papilloma virus (HPV), hepatitis B or C virus (HBV/HCV), and Merkel cell polyomavirus (MCPyV) that have not responded to previous treatments or have relapsed, or in adults who do not want to have surgery because of disfigurement or other risks. Adults who have HIV with any CD4 T cell count are eligible. Design: Participants will be screened with blood and urine tests, scans, and heart tests. They will have a physical exam. Their ability to perform normal daily activities will be assessed. They may have a tumor biopsy. Treatment will be given in 28-day cycles. Participants will take pomalidomide as a tablet by mouth for 21 days of each cycle, for up to 24 cycles. They will get nivolumab by intravenous infusion once each cycle. They will take an aspirin each day until 30 days after their last dose of the study drugs. Participants will keep a pill diary. They will bring it to their study visit at the end of each cycle. At these visits, some screening tests will be repeated. Participants with Kaposi sarcoma will have pictures taken of their lesions. Participants will give blood and saliva samples for research. They may have optional anal and/or cervical swabs. They may have optional biopsies. Participants will have a follow-up visit 30 days after they stop taking the study drugs, then every month for 100 days. Some screening tests will be repeated. Then they may by contacted by phone every 3 months for 9 months, and then every 6 months thereafter....

Phase 1
Recruiting

National Institutes of Health Clinical Center

Ramya M Ramaswami, M.D.

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