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Macrolide Antibiotic
Ixazomib Combo for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Research Sponsored by Joseph Tuscano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a confirmed biopsy diagnosis of a multiple myeloma
Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of the antibiotic clarithromycin when given with the drugs ixazomib citrate, pomalidomide, and dexamethasone to patients who have multiple myeloma that has not responded to previous treatment.
Who is the study for?
This trial is for patients with multiple myeloma that's gotten worse after treatment. They must have had a biopsy confirming the diagnosis, measurable disease, and be in fairly good health (ECOG status 0-2). Participants need to agree to use contraception and should not have other serious illnesses or recent treatments that could affect the study drugs' absorption or their own recovery.Check my eligibility
What is being tested?
The trial is testing clarithromycin combined with ixazomib citrate, pomalidomide, and dexamethasone on patients whose multiple myeloma has resisted previous treatments. It aims to find the safest dose of clarithromycin when used with these drugs and see how well this combination works against cancer cells.See study design
What are the potential side effects?
Possible side effects include immune system reactions, potential growth inhibition of healthy cells leading to blood disorders, digestive issues due to oral drug intake interference, nerve damage which may cause pain or numbness (peripheral neuropathy), infection risks from weakened immunity, heart conditions worsening due to stress on cardiovascular systems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of multiple myeloma from a biopsy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD of clarithromycin when given in combination with ixazomib citrate, pomalidomide, and dexamethasone assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Secondary outcome measures
Clinical best response
Other outcome measures
Change in immune modulation with the addition of clarithromycin (Phase II)
Change in immune modulation without the addition of clarithromycin (Phase II)
Pharmacokinetic parameters of ixazomib citrate (Individual and mean plasma ixazomib concentration data)
Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
EPISTAXIS
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
WEIGHT INCREASED
6%
DECUBITUS ULCER
6%
NEUROPATHY PERIPHERAL
6%
CYSTITIS
6%
GASTROENTERITIS
6%
DIABETES MELLITUS
6%
HEADACHE
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
RESTLESSNESS
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (PiC-D therapy)Experimental Treatment4 Interventions
Patients receive pomalidomide PO QD on days 1-21; ixazomib citrate PO on days 1, 8, and 15; clarithromycin PO BID on days 15-21 of course 1 and days 1-21 of courses 2-6; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY:
Patients receive pomalidomide, ixazomib citrate, and dexamethasone as above and receive clarithromycin PO BID or QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Ixazomib Citrate
2012
Completed Phase 2
~200
Clarithromycin
2017
Completed Phase 4
~3950
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,941 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,833 Patients Enrolled for Multiple Myeloma
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
152 Total Patients Enrolled
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,232 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,203 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I have not had major surgery in the last 14 days.I have not had radiotherapy in the last 14 days.You have HIV infection that meets certain criteria.I have had an allergic reaction to immune system drugs before.I have been treated with ixazomib or pomalidomide before.I have been cancer-free for over 5 years, except for nonmelanoma skin cancer or carcinoma in situ which was fully removed.I am following the required birth control measures.My cancer has spread to my brain or spinal cord.I am following the required contraceptive measures.I have severe nerve damage in my hands or feet, or moderate with pain.I haven't taken clarithromycin, anti-myeloma therapy, or had plasmapheresis in the last 30 days.Your blood needs to have certain levels of different components for you to qualify.I have a heart condition that is not currently under control.I have a confirmed diagnosis of multiple myeloma from a biopsy.My condition worsened within 6 months after stopping bortezomib and lenalidomide treatment.Patients must have a measurable amount of disease based on specific criteria from the International Myeloma Working Group.I do not have any ongoing infections, including hepatitis B or C.I can take care of myself and am up and about more than half of my waking hours.I still feel side effects from my last chemotherapy.I have a stomach or intestine condition that affects how I absorb pills.You are expected to live for more than 3 months.I haven't needed antibiotics for an infection in the last 14 days.I haven't taken any systemic treatments or specific drugs in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (PiC-D therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pomalidomide been tested in other research settings previously?
"Currently, 617 studies related to the use of pomalidomide are being conducted. Specifically, 156 trials have progressed far enough that they are currently in Phase 3. With 19680 locations worldwide participating in these investigations, Mishawaka Indiana is a prominent site for this research."
Answered by AI
What medical conditions can Pomalidomide be utilized to address?
"Pomalidomide has been proven to be an effective treatment for ophthalmia, sympathetic occlusion of branch retinal veins, and macular edema."
Answered by AI
What is the participant count of this experiment?
"Unfortunately, participants are no longer being sought for this trial. It was initially posted on October 1st 2015 and the post has not been updated since March 14th 2022. However, if you seek other trials related to multiple myeloma or Pomalidomide there are currently 818 studies with open recruitment and 617 trials recruiting patients respectively."
Answered by AI
Are recruitment events still ongoing for this medical experiment?
"This clinical trial is currently not recruiting any new candidates. The most recent edition of the study was published on March 14th, 2022 and it first posted in October 1st 2015. For individuals looking for other opportunities, there are 818 medical trials actively enrolling patients with multiple myeloma and 617 trials that use pomalidomide as a therapy option."
Answered by AI
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