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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

RASH MACULO-PAPULAR

Pharyngitis

HYPERGLYCAEMIA

HYPOPHOSPHATAEMIA

HYPOXIA

ANXIETY

MYALGIA

HEPATIC FUNCTION ABNORMAL

HERPES ZOSTER

CANCER PAIN

DECUBITUS ULCER

PERIPHERAL SENSORY NEUROPATHY

INCREASED APPETITE

CYSTITIS

DIABETES MELLITUS

GASTROENTERITIS

RESTLESSNESS

HEADACHE

NEUROPATHY PERIPHERAL

WEIGHT INCREASED

HYPOTENSION

HYPOGAMMAGLOBULINAEMIA

ABDOMINAL PAIN UPPER

HAEMORRHOIDS

ASTHMA

VOMITING

BRONCHITIS

HYPERCALCAEMIA

HYPOCALCAEMIA

HYPONATRAEMIA

HYPERSOMNIA

DYSPHONIA

PLEURAL EFFUSION

HICCUPS

ALANINE AMINOTRANSFERASE INCREASED

ASPARTATE AMINOTRANSFERASE INCREASED

BLOOD ALKALINE PHOSPHATASE INCREASED

MUSCLE SPASMS

WEIGHT DECREASED

TREMOR

HYPOTHYROIDISM

SOMNOLENCE

PROCTALGIA

DYSPNOEA

PNEUMONIA PNEUMOCOCCAL

MULTI-ORGAN FAILURE

PNEUMOCYSTIS JIROVECII PNEUMONIA

SEPSIS

INTERSTITIAL LUNG DISEASE

C-REACTIVE PROTEIN INCREASED

CARDIAC FAILURE

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

URINARY RETENTION

MENINGITIS

SPINAL COMPRESSION FRACTURE

BLOOD FIBRINOGEN DECREASED

BACK PAIN

SHOCK HAEMORRHAGIC

100%

80%

60%

40%

20%

Study treatment Arm

Pomalidomide Plus Dexamethasone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1060

Ixazomib Citrate

2012

Completed Phase 3

~970