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

NCT06252792 | Not Yet Recruiting DMC

• 1 other identifier: First relapse multiple myeloma
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma; First Relapse

Keywords

Multiple Myeloma; First relapse; the second progression free survival time (PFS2)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Objective Response Rate (ORR)

  through study completion, up to 2 years

• Deep response rate (≥ VGPR)

  through study completion, up to 2 years

• MRD negative

  through study completion, up to 2 years

• continuous MRD negative rate

  through study completion, up to 2 years

• Overall survival (OS)

  through study completion, up to 2 years

Study Arms (2)

daratumumab, pomalidomide, and dexamethasone (Dara-PD)

the first relapse of patients who received daratumumab, pomalidomide, and dexamethasone (Dara-PD) treatment

other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd)

the first relapse of patients who received other regimens in the same period (including Dara-KPD, VPd, KPd, IPd, Pd) treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the first relapse of multiple myeloma

You may qualify if:

• Age 18 years or older, regardless of gender.
• Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease
• First relapse of multiple myeloma;
• Receiving first-line anti-multiple myeloma therapy;
• The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);
• 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;
• 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.
• 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.

You may not qualify if:

• Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.
• 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；
• 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；
• Subject has received daratumumab or pomalidomide previously；
• 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).；
• Subjects with uncontrollable psychiatric disorders;
• 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.

Sponsors & Collaborators

• FengYan Jin: lead
• Affiliated Hospital of Hebei University: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• First Affiliated Hospital of Jinan University: collaborator
• Sun Yat-sen University: collaborator

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Biospecimen

Retention: SAMPLES WITH DNA

blood、bone marrow

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Hematology Department

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 12, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06