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Antibiotic

Pomalidomide with Stem Cell Transplant for Multiple Myeloma

Q: What conditions does Pomalidomide offer relief for?

Pomalidomide can be used to manage ophthalmia, sympathetic inflammation, branch retinal vein occlusions and macular edema.

Q: Are there still opportunities to join this clinical trial?

The information hosted on clinicaltrials.gov makes it clear that this medical experiment is not actively recruiting at the moment, despite having been initially posted in December 2012 and updated as recently as January 2022. Nevertheless, there are an abundance of other trials requiring participants presently.

Q: In how many distinct areas is this medical trial being carried out?

Ten trial sites are enrolling patients, with prominent locations such as Memorial Sloan Kettering <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center at Mercy Medical Center in Rockville Centre, Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center in Sleepy Hollow and Memorial Sloan Kettering West Harrison situated in Harrison.

Q: Are there any prior investigations that have explored the effects of Pomalidomide?

As of now, 595 Pomalidomide studies are underway with 153 in Phase 3. While Joliet, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> is a common locale for such trials, there are actually 18965 locations conducting research related to the drug.

Q: Are there any known adverse effects associated with Pomalidomide usage?

Although there is some evidence of Pomalidomide's safety, the lack of clinical data demonstrating efficacy means that it received a score of 2 on Power's risk assessment scale.

Q: To what capacity is this trial accommodating participants?

This trial is currently not accepting patients as the last update was on January 21st 2022. If you are seeking other studies, there are 807 trials for <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a> and 595 for pomalidomide actively recruiting participants at present.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

overall response rate

Secondary outcome measures

Determine the rates of ≥ Grade 3 toxicities

overall survival

progression free survival

+1 more

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%

EPISTAXIS

11%

FATIGUE

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

GASTROENTERITIS

HEADACHE

CANCER PAIN

CYSTITIS

WEIGHT INCREASED

DECUBITUS ULCER

NEUROPATHY PERIPHERAL

DIABETES MELLITUS

PERIPHERAL SENSORY NEUROPATHY

INCREASED APPETITE

RESTLESSNESS

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

SEPSIS

PNEUMOCYSTIS JIROVECII PNEUMONIA

PNEUMONIA PNEUMOCOCCAL

MULTI-ORGAN FAILURE

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

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

~2590

Clarithromycin

2017

Completed Phase 4

~3950

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityOTHER

1,054 Previous Clinical Trials

1,316,505 Total Patients Enrolled

18 Trials studying Multiple Myeloma

748 Patients Enrolled for Multiple Myeloma

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,597 Total Patients Enrolled

80 Trials studying Multiple Myeloma

86,144 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions does Pomalidomide offer relief for?

"Pomalidomide can be used to manage ophthalmia, sympathetic inflammation, branch retinal vein occlusions and macular edema."

Answered by AI

Are there still opportunities to join this clinical trial?

"The information hosted on clinicaltrials.gov makes it clear that this medical experiment is not actively recruiting at the moment, despite having been initially posted in December 2012 and updated as recently as January 2022. Nevertheless, there are an abundance of other trials requiring participants presently."

Answered by AI

In how many distinct areas is this medical trial being carried out?

"Ten trial sites are enrolling patients, with prominent locations such as Memorial Sloan Kettering Cancer Center at Mercy Medical Center in Rockville Centre, Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center in Sleepy Hollow and Memorial Sloan Kettering West Harrison situated in Harrison."

Answered by AI

Are there any prior investigations that have explored the effects of Pomalidomide?

"As of now, 595 Pomalidomide studies are underway with 153 in Phase 3. While Joliet, Illinois is a common locale for such trials, there are actually 18965 locations conducting research related to the drug."

Answered by AI

Are there any known adverse effects associated with Pomalidomide usage?

"Although there is some evidence of Pomalidomide's safety, the lack of clinical data demonstrating efficacy means that it received a score of 2 on Power's risk assessment scale."

Answered by AI

To what capacity is this trial accommodating participants?

"This trial is currently not accepting patients as the last update was on January 21st 2022. If you are seeking other studies, there are 807 trials for multiple myeloma and 595 for pomalidomide actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

2012. "Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01745588.

All > Stem Cell Transplant > Myeloma