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A Trial for Relapsed and Relapsed/Refractory Multiple Myeloma Patients

NCT04124497 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-08-08

No results posted yet for this study

Summary

Multiple myeloma (MM) with chromosome 17 deletion (del(17p) represents one of the most dangerous genetic variant of this disease, since it is associated with a high level of genomic instability. Del(17p) is present in approximately 10% of patients at diagnosis, and its frequency increases with disease evolution. The adverse prognosis of del(17p) has been observed in patients treated with conventional chemotherapy and new drugs. Only very few studies have suggested an advantage in treating del(17p) MM patients with specific therapies. In particular, several recent trials combining lenalidomide plus dexamethasone with a new agent, suggested that high risk cytogenetics patients may benefit from newest generation drugs. Yet, in all studies, outcome of patients with high risk genetic features have been derived from subgroup analyses, with all the limitations of this approach. To date no trial has been designed with the specific aim to test genotype-adapted therapies.

The objective of the present study is to evaluate the combination of daratumumab-pomalidomide-dexamethasone (DPd) in relapsed or relapsed/refractory MM patients harboring del(17p).

Treatment of relapsed or relapsed/refractory MM patients harbouring del(17p) is a relevant unmet medical need. A clinical trial designed to test a tailored treatment for this patient population would be a major improvement. In this perspective the combination DPd seems attractive since:

* both daratumumab and pomalidomide are therapies not interfering with DNA replication, thus not increasing the intrinsic genomic instability of del(17p) plasma cells.
* the POLLUX study has shown that daratumumab in combination with lenalidomide is highly effective in relapsed and relapsed/refractory MM patients.10
* the IFM 2010-02 trial has suggested that pomalidomide may be effective in del(17p) patients.
* the DPd combination has been successfully tested in MM patients with advanced disease.

Conditions

Interventions

DRUG

Daratumumab

* Daratumumab 16 mg/kg intravenously at following schedule: * cycle 1 and 2: days 1, 8, 15, and 22 * cycle 3 through 6: days 1, and 15 * from cycle 7 until disease progression: day 1.

DRUG

Pomalidomide

4 mg once daily on days 1-21

DRUG

Dexamethasone

Oral or intravenous dexamethasone 40 mg/day (≤ 75 years old) or 20 mg/ day (\>75 years old) on days 1, 8, 15 and 22

Sponsors & Collaborators

  • Fondazione EMN Italy Onlus

    lead OTHER

Principal Investigators

  • Vittorio Montefusco · Ospedale San Carlo Borromeo - Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04124497 on ClinicalTrials.gov