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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

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
Select...
My multiple myeloma has returned after treatment, as confirmed by tests.
Select...
I can take care of myself and perform normal activities without assistance.
Select...
My doctor expects me to live for at least 12 more weeks.
Select...
I have enough stem cells collected for a transplant.
Select...
I had a stem cell transplant that worked for at least a year without my cancer getting worse.
Select...
I am 18 years old or older.
Select...
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:
Select...
I do not have any uncontrolled illnesses that would affect my participation.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have previously used thalidomide or pomalidomide.
Select...
I am allergic to lenalidomide, thalidomide, clarithromycin, or melphalan.

Timeline

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
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

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
~1020
stem cell
2005
Completed Phase 2
~40
Dexamethasone
2007
Completed Phase 4
~2640
Clarithromycin
2017
Completed Phase 4
~3950

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER
1,077 Previous Clinical Trials
1,320,644 Total Patients Enrolled
18 Trials studying Multiple Myeloma
651 Patients Enrolled for Multiple Myeloma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,533 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,154 Patients Enrolled for Multiple Myeloma
Rutgers Cancer Institute of New JerseyOTHER
70 Previous Clinical Trials
18,734 Total Patients Enrolled
2 Trials studying Multiple Myeloma
30 Patients Enrolled for Multiple Myeloma

Media Library

Clarithromycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01745588 — Phase 2
Multiple Myeloma Research Study Groups: Clarithromycin + Pomalidomide + Dexamethasone + stem cell, Clarithromycin + Pomalidomide + Dexamethasone Alone
Multiple Myeloma Clinical Trial 2023: Clarithromycin Highlights & Side Effects. Trial Name: NCT01745588 — Phase 2
Clarithromycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01745588 — Phase 2
~2 spots leftby Dec 2025
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