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Antibiotic

Pomalidomide with Stem Cell Transplant for Multiple Myeloma

Phase 2

Waitlist Available

Led By Sergio Giralt, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed relapsed multiple myeloma as defined by the International Myeloma Working Group (IMWG).

KPS ≥ 70 or ECOG < 1.

Must not have

Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients with CNS involvement.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether the drug pomalidomide can help reduce myeloma cells in bones, and whether it's better to use it with or without a stem cell transplant.

Who is the study for?

This trial is for adults over 18 with relapsed multiple myeloma who've had a stem cell transplant and remission lasting at least 12 months. They must have measurable disease, good organ/marrow function, be able to take blood thinners, understand the study consent, and comply with POMALYST REMS™ program requirements.

What is being tested?

The trial compares two treatments using pomalidomide: one group gets an autologous stem cell transplant followed by maintenance pomalidomide; the other continues on clarithromycin/pomalidomide/dexamethasone (ClaPD) therapy before switching to pomalidomide maintenance.

What are the potential side effects?

Possible side effects include blood clots, bone marrow suppression leading to low blood counts, increased risk of infections due to weakened immune system, allergic reactions similar to those from thalidomide or lenalidomide, and potential heart or psychiatric issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has returned after treatment, as confirmed by tests.

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I can take care of myself and perform normal activities without assistance.

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My doctor expects me to live for at least 12 more weeks.

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I have enough stem cells collected for a transplant.

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I had a stem cell transplant that worked for at least a year without my cancer getting worse.

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I am 18 years old or older.

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I had a stem cell transplant and took lenalidomide as maintenance therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses that would affect my participation.

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My cancer has spread to my brain or spinal cord.

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I have previously used thalidomide or pomalidomide.

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I am allergic to lenalidomide, thalidomide, clarithromycin, or melphalan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

overall response rate

Secondary study objectives

Determine the rates of ≥ Grade 3 toxicities

safety analyses

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

2Treatment groups

Experimental Treatment

Group I: Clarithromycin + Pomalidomide + Dexamethasone AloneExperimental Treatment3 Interventions

All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD.

Group II: Clarithromycin + Pomalidomide + Dexamethasone + stem cellExperimental Treatment3 Interventions

All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pomalidomide

2011

Completed Phase 2

~1060

stem cell

2005

Completed Phase 2

~40