Ixazomib for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Karolinska Universitetssjukhuset Solna, Stockholm, Sweden
Lymphoma+2 More
Ixazomib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can be used to treat multiple myeloma.

See full description

Eligible Conditions

  • Lymphoma
  • Multiple Myeloma
  • Amyloidosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lymphoma

Study Objectives

This trial is evaluating whether Ixazomib will improve 6 primary outcomes in patients with Lymphoma. Measurement will happen over the course of Up to 5 years.

Up to 5 years
Number of Participants With New Primary Malignancies
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug
Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event
Number of Participants With ≥ Grade 2 Peripheral Neuropathy
Number of Participants With ≥ Grade 3 AEs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lymphoma

Side Effects for

Ixazomib+ LenDex (Exposure Up to 18 Cycles)
Diarrhoea
42%
Oedema peripheral
40%
Constipation
36%
Nausea
34%
Anaemia
31%
Fatigue
25%
Vomiting
25%
Rash maculo-papular
23%
Asthenia
22%
Decreased appetite
21%
Hypokalaemia
20%
Thrombocytopenia
20%
Insomnia
18%
Pyrexia
18%
Dizziness
17%
Cough
17%
Back pain
16%
Weight decreased
15%
Peripheral sensory neuropathy
14%
Anxiety
13%
Dyspnoea
13%
Pneumonia
12%
Urinary tract infection
12%
Pain in extremity
11%
Depression
11%
Arthralgia
10%
Hypotension
10%
Confusional state
10%
Headache
9%
Tremor
9%
Muscle spasms
9%
Neutropenia
9%
Bronchitis
8%
Pruritus
8%
Nasopharyngitis
8%
Chills
7%
Dry mouth
7%
Dry skin
7%
Rash macular
7%
Erythema
7%
Musculoskeletal chest pain
7%
Hyponatraemia
6%
Musculoskeletal pain
6%
Dysgeusia
6%
Paraesthesia
6%
Upper respiratory tract infection
6%
Stomatitis
6%
Rash
6%
Night sweats
6%
Muscular weakness
6%
Dehydration
6%
Hypophosphataemia
6%
Cardiac failure
6%
Fall
5%
Rash papular
5%
Peripheral swelling
5%
Abdominal pain upper
5%
Neck pain
4%
Blood creatinine increased
4%
Rash erythematous
4%
Abdominal pain
4%
Hypocalcaemia
4%
Hypomagnesaemia
4%
Epistaxis
4%
Hypertension
4%
Atrial fibrillation
4%
Myalgia
3%
Hyperhidrosis
3%
General physical health deterioration
3%
Syncope
3%
Acute kidney injury
3%
Dyspepsia
3%
Deep vein thrombosis
3%
Neutrophil count decreased
3%
Cardiac arrest
2%
Septic shock
2%
Gastroenteritis
2%
Staphylococcal sepsis
2%
Plasma cell myeloma
2%
Pulmonary embolism
2%
Respiratory failure
2%
Pathological fracture
2%
Febrile neutropenia
2%
Bone pain
2%
Pneumonia aspiration
2%
Somnolence
2%
Sepsis
2%
Papillary thyroid cancer
1%
Lower gastrointestinal haemorrhage
1%
Gastritis
1%
Malaise
1%
Pain
1%
Renal impairment
1%
Oesophagitis
1%
Acute pulmonary oedema
1%
Pyelonephritis
1%
Dermatitis allergic
1%
Spinal claudication
1%
Accidental overdose
1%
Lung infection
1%
Lower respiratory tract infection
1%
Cellulitis
1%
Toxic shock syndrome staphylococcal
1%
Influenza
1%
Parainfluenzae virus infection
1%
Tonsillitis
1%
Erysipelas
1%
Escherichia sepsis
1%
Pneumonia haemophilus
1%
Gastric cancer
1%
Bronchopulmonary aspergillosis
1%
Endocarditis
1%
Erythroleukaemia
1%
Adenocarcinoma of colon
1%
Basal cell carcinoma
1%
Adenocarcinoma pancreas
1%
Rectal haemorrhage
1%
Small intestinal obstruction
1%
Colitis
1%
Intestinal obstruction
1%
Faecaloma
1%
Death
1%
Non-cardiac chest pain
1%
Systemic inflammatory response syndrome
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Thalamic infarction
1%
Seizure
1%
Transient ischaemic attack
1%
Demyelinating polyneuropathy
1%
Cardiac failure congestive
1%
Angina unstable
1%
Atrioventricular block complete
1%
Chronic obstructive pulmonary disease
1%
Ischaemic cardiomyopathy
1%
Asthma
1%
Acute respiratory failure
1%
Spinal pain
1%
Kyphosis
1%
Spinal stenosis
1%
Chondrocalcinosis pyrophosphate
1%
Synovitis
1%
Humerus fracture
1%
Femoral neck fracture
1%
Aortic injury
1%
Hypercalcaemia
1%
Fluid overload
1%
Toxic skin eruption
1%
Stevens-Johnson syndrome
1%
Toxic epidermal necrolysis
1%
Renal failure
1%
Phlebitis
1%
Hallucination
1%
Obsessive thoughts
1%
Cholecystitis
1%
Cholelithiasis
1%
Hepatic function abnormal
1%
Hypovolaemic shock
1%
Productive cough
1%
Nephritis
1%
Intestinal perforation
1%
Sudden death
1%
Cerebral haematoma
1%
Haemorrhage intracranial
1%
Intraventricular haemorrhage
1%
Nervous system disorder
1%
Acute myocardial infarction
1%
Intervertebral disc protrusion
1%
Radius fracture
1%
Overdose
1%
Malnutrition
1%
Soft tissue infection
1%
Drug eruption
1%
Testicular oedema
1%
Peripheral ischaemia
1%
Anaphylactic reaction
1%
Embolism
1%
Cardiomyopathy
1%
Rash generalised
1%
Metastatic malignant melanoma
0%
Large granular lymphocytosis
0%
Abdominal adhesions
0%
Influenza like illness
0%
Acute coronary syndrome
0%
Acute respiratory distress syndrome
0%
Sarcopenia
0%
Spinal osteoarthritis
0%
Mobility decreased
0%
Haemorrhoids
0%
Rhinitis
0%
Hyperglycaemia
0%
Dyspnoea exertional
0%
Contusion
0%
Cataract
0%
Abdominal wall haematoma
0%
Myocardial ischaemia
0%
Venous thrombosis limb
0%
Renal tubular disorder
0%
Platelet count decreased
0%
Procedural pain
0%
Hypoacusis
0%
Diabetic ketoacidosis
0%
Volvulus
0%
Bartholinitis
0%
Complication associated with device
0%
Atrial flutter
0%
Right ventricular failure
0%
Crystal arthropathy
0%
Osteolysis
0%
Ventricular tachycardia
0%
Dysphonia
0%
Respiratory tract infection
0%
Lethargy
0%
Gastrooesophageal reflux disease
0%
Atypical pneumonia
0%
Pleural infection
0%
Pulmonary sepsis
0%
Sepsis syndrome
0%
Superinfection bacterial
0%
Urticaria
0%
Peritonitis
0%
Arthritis bacterial
0%
Cystitis bacterial
0%
Diverticulitis
0%
Appendicitis
0%
Appendicitis perforated
0%
Prostatitis Escherichia coli
0%
Staphylococcal bacteraemia
0%
Lower respiratory tract infection viral
0%
Cellulitis staphylococcal
0%
Abscess jaw
0%
Viral upper respiratory tract infection
0%
Pneumonia influenzal
0%
Campylobacter gastroenteritis
0%
Sinusitis aspergillus
0%
Pneumonia pneumococcal
0%
Viral uveitis
0%
Osteomyelitis
0%
Bursitis infective
0%
Pneumonia legionella
0%
Device related infection
0%
Pneumonia parainfluenzae viral
0%
Plasma cell leukaemia
0%
Bowen's disease
0%
Fungal oesophagitis
0%
Pseudomonal sepsis
0%
Respiratory syncytial virus infection
0%
Clostridium difficile colitis
0%
Tooth infection
0%
Meningitis
0%
Hepatitis E
0%
Prostate cancer recurrent
0%
Pancreatic carcinoma
0%
Bladder transitional cell carcinoma
0%
Malignant melanoma
0%
Breast cancer
0%
Lung neoplasm malignant
0%
Hypoaesthesia
0%
Sciatica
0%
Neuropathy peripheral
0%
Colon adenoma
0%
Cancer pain
0%
Squamous cell carcinoma of lung
0%
Sarcomatoid carcinoma
0%
Transitional cell cancer of the renal pelvis and ureter
0%
Metastases to liver
0%
Squamous cell carcinoma
0%
Chronic myeloid leukaemia
0%
Small intestinal haemorrhage
0%
Large intestine perforation
0%
Enterocolitis haemorrhagic
0%
Pancreatitis acute
0%
Pancreatitis
0%
Retroperitoneal haemorrhage
0%
Periodontal disease
0%
Inguinal hernia
0%
Umbilical hernia
0%
Rectal prolapse
0%
Intestinal ischaemia
0%
Proctalgia
0%
Duodenal ulcer
0%
Gastric volvulus
0%
Multiple organ dysfunction syndrome
0%
Chest pain
0%
Hyperthermia
0%
Stent-graft endoleak
0%
Thalamus haemorrhage
0%
Incarcerated hernia
0%
Cerebral haemorrhage
0%
Loss of consciousness
0%
Cerebral infarction
0%
Epilepsy
0%
Presyncope
0%
Spinal cord compression
0%
Cervicobrachial syndrome
0%
Peroneal nerve palsy
0%
Hepatic encephalopathy
0%
Hypoxic-ischaemic encephalopathy
0%
Hyperaesthesia
0%
Hemiplegia
0%
Supraventricular tachycardia
0%
Sinus bradycardia
0%
Angina pectoris
0%
Myocardial infarction
0%
Cardio-respiratory arrest
0%
Coronary artery disease
0%
Interstitial lung disease
0%
Lung infiltration
0%
Pulmonary oedema
0%
Hypoxia
0%
Haemoptysis
0%
Paranasal cyst
0%
Pleural effusion
0%
Haemarthrosis
0%
Arthritis
0%
Bone lesion
0%
Sinusitis
0%
Conjunctivitis
0%
Hip fracture
0%
Ankle fracture
0%
Lower limb fracture
0%
Ulna fracture
0%
Spinal compression fracture
0%
Cervical vertebral fracture
0%
Thoracic vertebral fracture
0%
Spinal fracture
0%
Joint dislocation
0%
Skin laceration
0%
Post procedural haemorrhage
0%
Hypervolaemia
0%
Tumour lysis syndrome
0%
Dermal cyst
0%
Decubitus ulcer
0%
Chronic kidney disease
0%
Urinary tract obstruction
0%
Focal segmental glomerulosclerosis
0%
Orthostatic hypotension
0%
Peripheral artery stenosis
0%
Aortic stenosis
0%
Delirium
0%
Cholecystitis acute
0%
Cholecystitis chronic
0%
Cholangitis acute
0%
Hepatic cirrhosis
0%
International normalised ratio increased
0%
Blood alkaline phosphatase increased
0%
Blast cells present
0%
Angle closure glaucoma
0%
Amaurosis
0%
Cystocele
0%
Device breakage
0%
Device loosening
0%
Thrombosis
0%
Herpes zoster
0%
Abdominal distension
0%
Toothache
0%
Cystitis
0%
Pharyngitis
0%
Osteoarthritis
0%
Joint swelling
0%
Gout
0%
Irritability
0%
Rhinorrhoea
0%
Oropharyngeal pain
0%
Hiccups
0%
Haematoma
0%
Flushing
0%
Hot flush
0%
Palpitations
0%
Vision blurred
0%
Vertigo
0%
Viral pharyngitis
0%
Squamous cell carcinoma of skin
0%
Colorectal adenocarcinoma
0%
Lung carcinoma cell type unspecified stage I
0%
Lacunar infarction
0%
Encephalopathy
0%
Posterior reversible encephalopathy syndrome
0%
Pneumonitis
0%
Prostate cancer
0%
Osteoporotic fracture
0%
Chondrocalcinosis
0%
Femur fracture
0%
Lumbar vertebral fracture
0%
Pelvic fracture
0%
Cystitis radiation
0%
Urinary retention postoperative
0%
Failure to thrive
0%
Gallbladder adenocarcinoma
0%
Superficial spreading melanoma stage unspecified
0%
Hypertensive heart disease
0%
Dental caries
0%
Haematuria
0%
Urinary retention
0%
Heparin-induced thrombocytopenia
0%
Staphylococcus test positive
0%
Benign prostatic hyperplasia
0%
Device malfunction
0%
Urosepsis
0%
Embolic stroke
0%
Eyelid ptosis
0%
Agitation
0%
Upper limb fracture
0%
Optic nerve sheath haemorrhage
0%
Pneumonia bacterial
0%
Enteritis
0%
Diverticular perforation
0%
Generalised oedema
0%
Drug reaction with eosinophilia and systemic symptoms
0%
Pruritus generalised
0%
Alopecia
0%
Dry eye
0%
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT01850524) in the Ixazomib+ LenDex (Exposure Up to 18 Cycles) ARM group. Side effects include: Diarrhoea with 42%, Oedema peripheral with 40%, Constipation with 36%, Nausea with 34%, Anaemia with 31%.

Trial Design

1 Treatment Group

Ixazomib
1 of 1
Experimental Treatment

This trial requires 31 total participants across 1 different treatment group

This trial involves a single treatment. Ixazomib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Ixazomib
Drug
Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Based on the findings of the investigator and the Takeda medical monitor, the study participant may continue to receive ixazomib and/or another investigational drug as part of the study, and does not have any other viable options to access the investigational drug. show original
Voluntary written consent must be obtained from all study participants before any study-related procedures that are not part of standard medical care are performed show original
The participant is on ixazomib monotherapy, a combination regimen with ixazomib and other study medication(s), on a placebo combination, or on an alternative arm regimen in a designated ixazomib parent study (i.e., Studies C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685], C16007 [NCT01318902], C16008 [NCT01383928], C16010 Global [NCT01564537], C16011 [NCT01659658], C16013 [NCT01645930], C16014 Global [NCT01850524] and Korean Continuation, C16017 [NCT01939899], C16020 [NCT02046070], C16029 [NCT03170882], and C16047 [NCT03439293]). show original
participants will not be able to continue in the study show original
I agree to continue practicing contraceptive methods as outlined in the parent study. show original

Patient Q&A Section

What are common treatments for multiple myeloma?

"In the United States, multiple myeloma accounts for approximately 1% of all cancer deaths. Current treatments for multiple myeloma are highly effective and improving in quality of life and survival. Future therapies to be studied in multicenter clinical trials include bortezomib and other proteasome inhibitors; immunomodulators and biologic drugs; and vaccines or growth-factor-derived cytokines." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"Between 30,000 and 40,000 people get multiple myeloma a year in the United States, and more than 1,600 people a year in the State of Connecticut." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma is most commonly of the nonsecretory types. The incidence of multiple myeloma peaks in middle age and old age which is in excess of the incidence of chronic lymphocytic leukemia and smoldering multiple myeloma. Survival is poor especially with the nonsecretory type, but this can be improved by treatment of both types with chemotherapy and/or radiotherapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Myeloma can be detected pre-symptomatically based on blood values such as a Bence Jones proteinuria, and by imaging such as radiographic abnormalities and increased serum globulin or paraprotein levels. In many patients at diagnosis, routine imaging studies often reveal lytic bone lesions that show no radiologic abnormality but are detectable with radionuclide imaging; bone lesions at diagnosis can be used as a substitute for imaging abnormalities on follow-up. Imaging abnormalities are most commonly found on the thorax but may also be found in the spine, and pelvis." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"MM is a disease that can be cured. However, recent disease-control advances have significantly improved the lives of patients with MM, and the outlook for those with symptomatic MM has improved." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"Many factors are known to be associated with increased risk of developing [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma), but in most cases multiple genetic and immunological defects are required for the disease to occur. The diagnosis of multiple myeloma is highly accurate but in many cases other diseases present with similar symptoms and signs because patients with the disease are too ill to be referred for evaluation. When patients with multiple myeloma are referred to a rheumatologist, a number of specific clinical scoring systems are utilized to help the diagnostic process. In view of the increasing longevity of patients with myeloma, the risk of the disease developing in others is of major importance." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple myeloma?

"Overall we found that multiple myeloma is rare among the very elderly, i.e. the 10% aged 85 years and older (compared to less than 20% among age 70 years and younger) and the average age of diagnosis of multiple myeloma is 63.5 years (compared to 54 years for those aged 70 y and younger)." - Anonymous Online Contributor

Unverified Answer

Does multiple myeloma run in families?

"The genetic basis of MM remains largely undefined although studies have indicated certain genetic risk factors, such as 1PO, for which the disease has recently (2003) been shown to occur earlier in families with a higher prevalence of 1PO-MM. The findings underscore the possible importance of genetic interaction effects." - Anonymous Online Contributor

Unverified Answer

Is ixazomib typically used in combination with any other treatments?

"As the overall use of ixzomib has become wider, the drug is used in combination with multiple other agents - most often with other proteasome inhibitors bortezomib or carfilzomib (e.g., with a pooled hazard ratio of 2.7, P<.01), a chemo therapy agent with proteasome inhibition (e.g., carboplatin, etoposide, or epirubicin with or without gemtuzumab ozogamicin), or platinum-based chemotherapeutics (e.g., cisplatin or carboplatin; hazard ratio = 2.8, P<.01)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ixazomib?

"Clinically used ixazomib is currently being studied in a Phase 3 trial as a single agent and in combination with vincristine and dexamethasone in patients with relapsed multiple myeloma. The first Phase 1 trial was completed in 2011. Results from a recent clinical trial and the Phase 3 trial will provide further information about safety and tolerability of ixazomib. Please [link to the clinicaltrials.gov website for the Phase 3 trial] if you have questions." - Anonymous Online Contributor

Unverified Answer

How quickly does multiple myeloma spread?

"There are several routes that the disease may spread, such as hematogenous (blood), lymphatic, and through the central nervous system. Most of the cases that would have been undetected on initial diagnosis because of lack of imaging have had a disease duration of 5 years or longer. Early detection of the disease will help the patient and physicians anticipate and manage treatment more effectively." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ixazomib for therapeutic use?

"Since the FDA approved approval of ixazomib, studies have shown the safety and efficacy of this agent as well as potential use in new treatment paradigms. These new findings provide an alternative approach to the management of MM." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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