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RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03908138
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Shandong Provincial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Multiple Myeloma Efficacy Safety Drug: RDD Drug: VDD Phase 4

Detailed Description:

The therapy regimens of MM were very limited before 2000, mainly including VAD (vincristine, doxorubicin, dexamethasone), methylpheniram, corticosteroids and autologous stem cell transplantation (ASCT). The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) in the 2000's significantly improved the survival of MM patients. Combined chemotherapy containing new drugs has become the first-line therapy for the treatment of newly diagnosed MM patients.

In addition to direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. The effects on immune system include reducing TNF-α, IL-1β, IL-6 and IL-12, increasing production of IL-2 and IFN-γ, increasing T cell initiation, enhancing the absorption of tumor antigen by dendritic cells (DCs), enhancing the efficiency of antigen presentation, inhibiting regulatory T cells (Treg), and enhancing the activity of natural killer cells (NK) and NKT cells. Lenalidomide, a kind of IMiDs, also have the effects on osteoclasts, which are important in bone disease in MM patients.

In 2006, the combination of lenalidomide and dexamethasone (RD) was approved in the United States for the treatment of relapsed/refractory MM. The RD regimen was approved for the treatment of newly diagnosed MM patients in 2015. Four lenalidomide-containing triple drug regimens were approved for the treatment of relapsed/refractory MM from 2015 to 2016. However, the application of lenalidomide-containing triple drug regimens in newly diagnosed patients with multiple myeloma needs to be further validated. Therefore, we designed the randomized controlled clinical study and aimed to compare the efficacy and safety between RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) and VDD (bortezomib, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized either receiving RDD or receiving VDD therapy.
Masking: None (Open Label)
Masking Description: no mask.
Primary Purpose: Treatment
Official Title: RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: RDD group
Lenalidomide: 25mg, po, d1-21， Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20-40mg, po, d1，d8，d15，d22
 Drug: RDD
Lenalidomide: 25mg, po, d1-21， Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20-40mg, po, d1，d8，d15，d22
Other Name: RDD group
Active Comparator: VDD group
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
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
Other Name: VDD group


Outcome Measures
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Primary Outcome Measures :
  1. complete response (CR) [ Time Frame: At 8 months ]
    meeting the standard IMWG response criteria (CR and VGCR) of NCCN guidelines (Version2. 2019)

  2. partial remission (PR) [ Time Frame: At 8 months ]
    meeting the standard IMWG response criteria (PR) of NCCN guidelines (Version2. 2019)


Secondary Outcome Measures :
  1. Progressive free survival [ Time Frame: At 3 months, 5 months, 8 months, 12 months, 18 months, 24 months and 36 months ]
    the length of time during and after the treatment of MM that a patient lives with the disease but it does not get worse

  2. overall survival (OS) [ Time Frame: At 3 months, 5 months, 8 months, 12 months, 18 months, 24 months and 36 months ]
    the percentage of MM patient who are alive after 3 years.


Other Outcome Measures:
  1. Side effects [ Time Frame: At 3 months, 5 months and 8 months ]
    Incidence of Treatment-Emergent Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908138


Contacts
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Contact: Xin Wang, PhD, MD +86-531-68778331 xinw@sdu.edu.cn
Contact: Xin Liu, PhD, MD +86-15168889791 13518611662@163.com

Locations
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China, Shandong
Department of Hematology, Provincial Hospital Affiliated to Shandong University Recruiting
Jin'an, Shandong, China, 250012
Contact: Xin Wang, MD, PHD    86-531-68778331    xinw007@126.com   
Contact: Xin Liu, MD,PHD    86-531-68778331    13518611662@163.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Principal Investigator: Xin Wang, PhD, MD Shandong Provincial Hospital
More Information
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Responsible Party: Wang Xin, Director of Hematology, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT03908138    
Other Study ID Numbers: ShandongPH03
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wang Xin, Shandong Provincial Hospital:
multiple myeloma
lenalidomide
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site