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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
Must not have
Female patients who are lactating or have a positive serum pregnancy test during the screening period
Major surgery within 14 days before enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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.
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.
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 below
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I have a confirmed diagnosis of multiple myeloma from a biopsy.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have not had major surgery in the last 14 days.
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I have had an allergic reaction to immune system drugs before.
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I have been treated with ixazomib or pomalidomide before.
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My cancer has spread to my brain or spinal cord.
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I have severe nerve damage in my hands or feet, or moderate with pain.
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I have a heart condition that is not currently under control.
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I do not have any ongoing infections, including hepatitis B or C.
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I have a stomach or intestine condition that affects how I absorb pills.
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I haven't taken any systemic treatments or specific drugs in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Clinical best response
Other study objectives
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 • NCT02011113
72%
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%
FATIGUE
11%
EPISTAXIS
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%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
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%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
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 3
~940
Clarithromycin
2017
Completed Phase 4
~3950
Dexamethasone
2007
Completed Phase 4
~2640

Find a Location

Who is running the clinical trial?

CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,519 Total Patients Enrolled
145 Trials studying Multiple Myeloma
41,773 Patients Enrolled for Multiple Myeloma
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
152 Total Patients Enrolled
TakedaIndustry Sponsor
1,227 Previous Clinical Trials
4,222,475 Total Patients Enrolled
50 Trials studying Multiple Myeloma
15,636 Patients Enrolled for Multiple Myeloma

Media Library

Clarithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT02542657 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Treatment (PiC-D therapy)
Multiple Myeloma Clinical Trial 2023: Clarithromycin Highlights & Side Effects. Trial Name: NCT02542657 — Phase 1 & 2
Clarithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02542657 — Phase 1 & 2
~3 spots leftby Sep 2025
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