Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252792
• Other study ID #: First relapse multiple myeloma
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: June 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.

Description:

To evaluate the impact of daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma. Among them, the second progression free survival time (PFS2) is defined as the time from enrollment to disease progression or death.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects will be enrolled in this study only if they met all of the following inclusion criteria.

1. Age 18 years or older, regardless of gender.

2. Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease

3. First relapse of multiple myeloma;

4. Receiving first-line anti-multiple myeloma therapy;

5. The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);

6. Subject must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen;

7. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.

8. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.

Exclusion Criteria:

1. Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.

2. Relapsed and refractory myeloma:Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course;

3. Primary refractory myeloma:Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy;

4. Subject has received daratumumab or pomalidomide previously;

5. Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).;

6. Subjects with uncontrollable psychiatric disorders;

7. Subject is known or suspected of not being able to comply with the study protocol.Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Related Conditions & MeSH terms

• First Relapse
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Recurrence

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
FengYan Jin	Affiliated Hospital of Hebei University, First Affiliated Hospital of Jinan University, Second Hospital of Shanxi Medical University, Shandong Cancer Hospital and Institute, Sun Yat-sen University

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the second progression free survival time (PFS2)	daratumumab, pomalidomide, and dexamethasone (Dara-PD) compared to other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) on the second progression free survival time (PFS2) of first relapse of multiple myeloma.	through study completion, up to 2 years
Secondary	Objective Response Rate (ORR)	Evaluated according to the 2016 IMWG efficacy evaluation criteria, defined as the proportion of participants who achieved the best response as strict complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).	through study completion, up to 2 years
Secondary	Deep response rate (= VGPR)	Evaluated according to the 2016 IMWG efficacy evaluation criteria, defined as the proportion of subjects who achieved the best response as strict complete response (sCR), complete response (CR), and very good partial response (VGPR).	through study completion, up to 2 years
Secondary	MRD negative	MRD negative is defined as bone marrow MRD negative confirmed by new generation flow cytometry (NGF) or new generation sequencing technology (NGS) (the minimum detection sensitivity is that one clonal plasma cell can be detected from 105 nucleated cells);	through study completion, up to 2 years
Secondary	continuous MRD negative rate	Persistent MRD negative: new generation flow cytometry (NGF) or new generation sequencing technology (NGS) detects bone marrow MRD negative and imaging negative, with at least one year between two tests being negative	through study completion, up to 2 years
Secondary	Overall survival (OS)	Overall survival (OS) evaluation: defined as the time from enrollment to death.	through study completion, up to 2 years
Secondary	Evaluation of duration of remission (DOR)	Evaluation of duration of remission (DOR): defined as the time from the first response to treatment to disease progression or death	through study completion, up to 2 years