pomalidomide for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple Myeloma+6 More
pomalidomide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the side-effects and best dose of two drugs, pomalidomide and bortezomib, when given together with dexamethasone, in treating patients with amyloid light-chain amyloidosis or light chain deposition disease.

Eligible Conditions
  • Multiple Myeloma
  • Light Chain Deposition Disease
  • Primary Systemic Amyloidosis (AL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 28 days

28 days
Maximum tolerated dose defined as the dose level before 2 of 6 patients experience dose-limiting toxicity (DLT) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Day 28
Overall survival
Up to 28 days
Complete hematologic response rate (hCR)
Organ response rates (heart, liver, kidney)
Overall hematologic response rate (partial response [PR] + complete response [CR])
Progression free survival

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pomalidomide Plus Low-Dose Dexamethasone
53%Anaemia
52%Neutropenia
34%Fatigue
29%Thrombocytopenia
25%Pyrexia
24%Constipation
24%Diarrhoea
21%Cough
20%Back pain
20%Dyspnoea
19%Pneumonia
19%Nausea
18%Asthenia
18%Bone pain
17%Oedema peripheral
16%Upper respiratory tract infection
16%Muscle spasms
13%Dizziness
13%Leukopenia
13%Decreased appetite
12%Insomnia
11%Bronchitis
10%Nasopharyngitis
10%Hypokalaemia
9%Arthralgia
9%Headache
9%General physical health deterioration
9%Peripheral sensory neuropathy
9%Epistaxis
8%Vomiting
8%Rash
7%Pruritus
7%Pain in extremity
6%Hyperglycaemia
6%Febrile neutropenia
6%Chills
6%Blood creatinine increased
6%Agitation
6%Urinary tract infection
6%Neutrophil count decreased
6%Musculoskeletal pain
6%Tremor
6%Dyspnoea exertional
6%Hyperhidrosis
5%Hypocalcaemia
5%Respiratory tract infection
5%Dehydration
5%Weight decreased
5%Anxiety
4%Hypercalcaemia
4%Acute kidney injury
4%Hypotension
4%Lymphopenia
4%Chest pain
4%Muscular weakness
4%Myalgia
4%Musculoskeletal chest pain
4%Paraesthesia
3%Abdominal pain upper
3%Erythema
3%Dry skin
3%Haematoma
3%Renal failure
3%Cataract
3%Fall
3%Lethargy
3%Neuropathy peripheral
3%Malaise
3%Oedema
3%Sinusitis
3%White blood cell count decreased
3%Confusional state
2%Palpitations
2%Pulmonary embolism
2%Herpes zoster
2%Cellulitis
2%Rib fracture
2%Productive cough
2%Atrial fibrillation
2%Femur fracture
2%Lung infection
2%Lower respiratory tract infection
2%Sepsis
2%Contusion
1%Spinal cord compression
1%Spinal pain
1%Cerebrovascular accident
1%Urinary retention
1%Pancytopenia
1%Cardiac failure
1%Diplopia
1%Ventricular tachycardia
1%Influenza
1%Multiple organ dysfunction syndrome
1%Hip fracture
1%Humerus fracture
1%Hyponatraemia
1%Depressed level of consciousness
1%Renal impairment
1%Chronic obstructive pulmonary disease
1%Adrenal insufficiency
1%Influenza like illness
1%Swelling face
1%Abdominal pain
1%Bacteraemia
1%Pneumocystis jirovecii pneumonia
1%Gastroenteritis
1%Infection
1%Pneumonia bacterial
1%Septic shock
1%Plasmacytoma
1%Basal cell carcinoma
1%Syncope
1%Lung disorder
1%Mouth ulceration
1%Myopathy
1%Osteolysis
1%Amnesia
1%Hot flush
1%Myocardial infarction
1%Escherichia sepsis
1%Pain
1%Device related infection
1%Cytomegalovirus chorioretinitis
1%Neutropenic sepsis
1%Respiratory failure
1%Deep vein thrombosis
1%Pathological fracture
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01311687) in the Pomalidomide Plus Low-Dose Dexamethasone ARM group. Side effects include: Anaemia with 53%, Neutropenia with 52%, Fatigue with 34%, Thrombocytopenia with 29%, Pyrexia with 25%.

Trial Design

1 Treatment Group

Treatment (pomalidomide, bortezomib, and dexamethasone)
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: pomalidomide · No Placebo Group · Phase 1

Treatment (pomalidomide, bortezomib, and dexamethasone)Experimental Group · 4 Interventions: pomalidomide, bortezomib, dexamethasone, Laboratory Biomarker Analysis · Intervention Types: Drug, Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Bortezomib D-mannitol
FDA approved
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor
159 Previous Clinical Trials
8,524 Total Patients Enrolled
23 Trials studying Multiple Myeloma
1,277 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,005 Previous Clinical Trials
41,301,891 Total Patients Enrolled
555 Trials studying Multiple Myeloma
193,108 Patients Enrolled for Multiple Myeloma
Jeffrey ZonderPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: November 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.