VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma

NCT03641456 | Unknown Phase 2 DMC

• 1 other identifier: MM-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The phase 2 study evaluated the efficacy and safety of bortezomib in combination with lenalidomide as maintenance therapy in high risk newly diagnosed multiple myeloma patients who receive lenalidomide,bortezomib, and dexamethasone Combination as induction therapy.

Conditions

Myeloma; Newly Diagnosed; High Risk

Outcome Measures

Primary Outcomes (1)

• Very good partial response or better by International Myeloma Working Group criteria

  Number of participants with very good partial response or better as Assessed by International Myeloma Working Group criteria，change from baseline.

  up to end of follow-up-phase (approximately 3 years)

Secondary Outcomes (5)

• progression free survival

  up to end of follow-up-phase (approximately 3 years)

• overall survival

  up to end of follow-up-phase (approximately 3 years)

• Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v 4.0

  up to end of follow-up-phase (approximately 3 years)

• complete response rate by International Myeloma Working Group criteria

  up to end of follow-up-phase (approximately 3 years)

• overall response rate by International Myeloma Working Group criteria

  up to end of follow-up-phase (approximately 3 years)

Study Arms (1)

VRD for Followed by VR

EXPERIMENTAL

The investigators gave patients subcutaneous bortezomib 1.3mg/m2 on days 1, 8,15, and 22; oral lenalidomide 25mg on days 1 to 21; and oral dexamethasone 40mg on days 1, 8, 15 and 12 of a 28-day cycle.Patients are allowed to proceed to stem-cell transplantation after four cycles of VRD at the discretion of the treating physician.Two months after hematologic recovery, nonprogressive patients are to receive consolidation therapy comprising two cycles of VRD.Patients who do not proceed to stem-cell transplantation receive more two induction cycles after obtaining maximum response but no less than six cycles totally. Responding patients could receive maintenance therapy comprising 4-week cycles of bortezomib 1.3mg/m2 on days 1 and 15 and lenalidomide on days 1 to 21 at the dose level of 10mg.

Drug: bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

bortezomib DRUG

The investigators gave patients subcutaneous bortezomib 1.3mg/m2 on days 1, 8,15, and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of bortezomib on days 1 and 15 at the dose level of 1.3mg/m2. Patients discontinued treatment if they had progressive disease or or unacceptable toxic effects not controlled with dose modifications.

Also known as: Velcade

VRD for Followed by VR

Lenalidomide DRUG

The investigators gave patients oral lenalidomide 25mg on days 1 to 21 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of lenalidomide on days 1 to 21 at the dose level of 10mg. Patients discontinued treatment if they had progressive disease or unacceptable toxic effects not controlled with dose modifications.

Also known as: Revlimid

VRD for Followed by VR

Dexamethasone DRUG

The investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.

Also known as: Dexamethasone Acetate

VRD for Followed by VR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a newly diagnosis of multiple myeloma
• Patient requires treatment for multiple myeloma
• Subject have high-risk characteristics.Our definition for high risk multiple myeloma :(1) with cytogenetic abnormalities including del(17p),t(4;14),t(14;16),and/or t(14;20) ;(2) R-ISS III；(3) ISS III and no complete remission is achieved before maintenance therapy.
• Subject has measurable disease as defined by \> 0.5 g/dL serum monoclonal protein, \>10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, \>0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI
• Subject has a Karnofsky performance status ≥60%
• Subject has a life expectancy ≥ 3 months
• Subjects must meet the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST \<3.0 x upper limits of normal (ULN) Serum SGPT/ALT \<3.0 x upper limits of normal (ULN) Serum total bilirubin \<2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 30 cc/min

You may not qualify if:

• Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning)
• Subject has a prior history of other malignancies unless disease-free for ≥ 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score \< 7 with stable prostate specific antigen (PSA) levels
• Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction \< 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Female subject who is pregnant or lactating
• Subject has known HIV infection
• Subject has known active hepatitis B or hepatitis C infection
• Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program
• Subject is unable to reliably take oral medications
• Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment
• Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Bortezomib; Lenalidomide; Dexamethasone; dexamethasone acetate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hua Wang, MD.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua wang, MD.

CONTACT

020-87342462; wanghua@sysucc.org.cn

Hua Wang, MD.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 22, 2018
• Study Start: September 25, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CN (1)