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

Celgene

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib; Drug: Pomalidomide; Drug: Dexamethasone

Study type: Observational

Funder types: Industry

Identifiers

NCT02555839

CC-4047-MM-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

127 participants in 2 patient groups

Pomalidomide and Dexamethasone

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Pomalidomide

Drug: Pomalidomide

Pomalidomide, Bortezomib and Dexamethasone

Description:

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

Treatment:

Drug: Dexamethasone

Drug: Dexamethasone

Drug: Bortezomib

Drug: Pomalidomide

Drug: Pomalidomide