Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)

NCT01782963 | Completed Phase 2 Results DMC

• 1 other identifier: 12-498
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational combination of drugs. The purpose is to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied. It also means that research doctors are trying to find out more about it. Examples of what they want to learn about are the safest dose to use, the side effects it may cause, and if the combination of drugs works for treating different types of cancer.

Conditions

Multiple Myeloma

Keywords

Newly diagnosed

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following: * Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) * CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in BM * VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours * PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required

  2 years

Secondary Outcomes (7)

• Number of Participants With Grade 3 or Higher Treatment Related Adverse Events

  2 years

• Median Progression Free Survival

  From the start of treatment until death or progression or until 3 years after the last participant is enrolled

• Median Overall Survival

  From the start of treatment until death or until 5 years after the time of disease progression

• Median Time to Response

  From the start of treatment until the time of first documented response, median duration of 1.1 months

• Response Rate With Respect to Cytogenetic Characteristics

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15

Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

Also known as: Revlimid

Treatment Arm

Bortezomib DRUG

Also known as: Velcade

Treatment Arm

Dexamethasone DRUG

Treatment Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented symptomatic myeloma, with organ damage related to myeloma
• Myeloma that is measurable either by serum or urine evaluation of the monoclonal component or by assay of serum free light chains
• Must commit to complete abstinence from heterosexual contact or begin two acceptable method of birth control, one highly effective method and one additional effective (barrier) method

You may not qualify if:

• Eligible for autologous stem cell transplantation
• HIV positive on combination antiretroviral therapy
• Pregnant or breastfeeding
• Treated with any prior systemic therapy
• Primary amyloidosis or myeloma complicated by amyloidosis
• Receiving other investigational agents within 14 days of the start of this trial or during this trial
• Known brain metastases
• Poor tolerability or known allergy to any of the study drugs or similar compounds
• Intercurrent illness
• Previous history of another malignant condition except for basal cell carcinoma or stage I cervical cancer
• Inability to comply with an anti-thrombotic treatment regimen
• Peripheral neuropathy greater than or equal to grade 2

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (6)

John Hopkins University

Baltimore, Maryland, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital/North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Bortezomib; Dexamethasone

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Noopur Raje, MD
• Organization: Massachusetts General Hospital

NRAJE@mgh.harvard.edu

617-724-4000

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: February 4, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 31, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-10

Locations

US (6)