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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice

Clinicaltrials.gov identifier NCT02555839

Recruitment Status Recruiting

First Posted September 22, 2015

Last update posted May 28, 2020

Study Description

Brief summary:

There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously treated with Lenalidomide and Bortezomib, due to poor prognosis. This observational study focuses on the collection of data concerning the safe and optimal usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage and efficacy will be performed. This knowledge could lead to a optimization of Pomalidomide usage and treatment.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Drug: Dexamethasone
    Drug: Pomalidomide
    Drug: Pomalidomide
    Drug: Dexamethasone
    Drug: Bortezomib
  • Phase: N/A
Detailed Description

There is a high unmet medical need for further anti-myeloma therapy in patients with RRMM who have previously been treated with Lenalidomide and Bortezomib containing regimens that is both active and tolerable, as these patients have a poor prognosis. Hands-on experience with Pomalidomide is very limited in Austria and a non-interventional study enhances the attention paid to safe use and handling of the product as well as increase knowledge about optimal adverse event (AE) management substantially. A detailed record of the medical history including. co-morbidities and pre-treatment regimens will allow analysis of the impact there of on tolerability, dosage and efficacy. Beside the collection of data on efficacy and tolerability this observational drug utilization study could give insight into the clinical practice and the routine use of Pomalidomide.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 150 participants
  • Observational Model: Cohort
  • Time Perspective: Cross-Sectional
  • Official Title: Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
  • Actual Study Start Date: March 2015
  • Estimated Primary Completion Date: September 2022
  • Estimated Study Completion Date: September 2022
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Pomalidomide and Dexamethasone
Pomalidomide 4mg capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
Drug: Pomalidomide
4mg capsule on d1 through 21 of a 28 day cycle

Drug: Dexamethasone
40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
: Pomalidomide, Bortezomib and Dexamethasone
Cycle 1-8: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle until progression or unacceptable toxicity; from cycle 9 onwards: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle until progression or unacceptable toxicity
Drug: Pomalidomide
4mg capsule on d1 through 14 of a 21 day cycle

Drug: Dexamethasone
cycle 1-8: 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle; from cycle 9 onwards: Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle

Drug: Bortezomib
cycle 1-8: Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle; from cycle 9 onwards: Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle,
Outcome Measures
  • Primary Outcome Measures: 1. Number of Adverse Events [ Time Frame: Up to 2 years ]
    The number of participant adverse events
  • Secondary Outcome Measures: 1. Response Rate [ Time Frame: Up to 2 years ]
    The number of participants who achieve a response
  • 2. Progression Free Survival [ Time Frame: Up to 2 years ]
    The number of participants who survive without progression of disease
  • 3. Duration of Response [ Time Frame: Up to 2 years ]
    Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Relapsed and/or Refractory Multiple Myeloma
Criteria

Inclusion Criteria:

- Signed IC

- age ≥ 18 years

- relapsed/refractory MM

- cohort A (combination pomalidomide und dexamethasone):

≥2 antimyeloma treatments (including lenalidomide and bortezomib), induction therapy
followed by ASCT and consolidation or maintenance therapy is considered as 1
antimyeloma treatment

- cohort B (combination pomalidomide, bortezomib and dexamethasone):

≥1 antimyeloma treatments (including lenalidomide) induction therapy followed by ASCT
and consolidation or maintenance therapy is considered as 1 antimyeloma treatment

- refractory to last antimyeloma treatment

- adequate contraception according to RMP

- adequate thrombosis prophylaxis

Exclusion Criteria:

1. Pregnant or Lactating Females

2. Known hypersensitivity to Imnovid

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 13 Study Locations
Sponsors and Collaborators

Celgene

Investigators

Study Chair: Guenter Voraberger, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT02555839 History of Changes
  • Other Study ID Numbers: CC-4047-MM-017
  • First Posted: September 22, 2015 Key Record Dates
  • Last Update Posted: May 28, 2020
  • Last Verified: May 2020
  • Keywords provided by Celgene: Relapsed Multiple Myeloma
    Refractory Multiple Myeloma
    Pomalidomide
    Imnovid
    Non-interventional
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell