RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

NCT03908138 | Unknown Phase 4 DMC

• 1 other identifier: ShandongPH03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple myeloma (MM) is a common malignant hematology disease. The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) significantly improved the survival of MM patients. IMiDs have multiple effects in MM therapy. Except for direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. Lenalidomide, a kind of IMiDs, was usually used in the therapy of relapsed/refractory MM. The efficacy and safety of RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM still needs to be further validated.

Conditions

Hematologic Neoplasms; Multiple Myeloma; Efficacy; Safety

Keywords

multiple myeloma; lenalidomide

Outcome Measures

Primary Outcomes (2)

• complete response (CR)

  meeting the standard IMWG response criteria (CR and VGCR) of NCCN guidelines (Version2. 2019)

  At 8 months

• partial remission (PR)

  meeting the standard IMWG response criteria (PR) of NCCN guidelines (Version2. 2019)

  At 8 months

Secondary Outcomes (2)

• Progressive free survival

  At 3 months, 5 months, 8 months, 12 months, 18 months, 24 months and 36 months

• overall survival (OS)

  At 3 months, 5 months, 8 months, 12 months, 18 months, 24 months and 36 months

Other Outcomes (1)

• Side effects

  At 3 months, 5 months and 8 months

Study Arms (2)

RDD group

ACTIVE COMPARATOR

Lenalidomide: 25mg, po, d1-21， Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20-40mg, po, d1，d8，d15，d22

Drug: RDD

VDD group

ACTIVE COMPARATOR

Bortezomib:1.3mg/m2，ih，d1，d4，d8，d11 Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20 mg, ivgtt, d1, 2, 4, 5, 8, 9, 11,12

Drug: VDD

Interventions

RDD DRUG

Lenalidomide: 25mg, po, d1-21， Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20-40mg, po, d1，d8，d15，d22

Also known as: RDD group

RDD group

VDD DRUG

Bortezomib:1.3mg/m2，ih，d1，d4，d8，d11 Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20 mg, ivgtt, d1, 2, 4, 5, 8, 9, 11,12

Also known as: VDD group

VDD group

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of symptomatic (active) MM;
• Ages ≥18 years old, ≤65 years old;
• ECOG score: 0-2;
• Liver function: transaminase≤2.5×upper limit of normal value，bilirubin≤1.5×upper limit of normal value;
• Renal function: serum creatinine is 44-176 mmol/L;
• LVEF≥50%;
• New York Heart Association (NYHA) heart function classification is I-II grade;
• Signed informed consent.

You may not qualify if:

• Severe complications or severe infection;
• Severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;
• Severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;
• Patients participate in other clinical studies;
• Patients are not suitable for the study;
• Other contraindications for ASCT therapy.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Department of Hematology, Provincial Hospital Affiliated to Shandong University

Jin'an, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Xin Wang, PhD, MD

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wang, PhD, MD

CONTACT

+86-531-68778331; xinw@sdu.edu.cn

Xin Liu, PhD, MD

CONTACT

+86-15168889791; 13518611662@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no mask.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology

Model Details: The patients will be randomized either receiving RDD or receiving VDD therapy.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 9, 2019
• Study Start: March 30, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)