Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) (RVD Lite)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Noopur Raje, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01782963
First received: January 15, 2013
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the objective response rate (PR [Partial Response] + VGPR [Very Good Partial Response] + CR [Complete Response]) of modified RVD (weekly subcutaneous bortezomib [Velcade], lenalidomide [Revlimid], and dexamethasone) in previously untreated multiple myeloma patients who are ineligible for high dose therapy with autologous stem cell transplant.


Secondary Outcome Measures:
  • Evaluation of Safety Profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate the safety profile of modified RVD in previously untreated MM patients who are transplant-ineligible

  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the progression-free survival of modified RVD

  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the overall survival of modified RVD

  • Time to Response and Response Duration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the time to response and response duration of modified RVD

  • Response Rate with Respect to Cytogenetic Characteristics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the response rate with respect to cytogenetic characteristics of the bone marrow plasma cells.

  • Evaluate Pharmacokinetic Profile [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.

  • Evaluate Pharmacogenomic Markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate pharmacogenomic markers among patients with treatment related neuropathy.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm

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
Other Name: Revlimid
Drug: Bortezomib
Other Name: Velcade
Drug: Dexamethasone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782963

Contacts
Contact: Noopur Raje, MD 6177260711 nraje@partners.org

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: David Avigan, MD    617-632-8696    daviga@bidmc.harvard.edu   
Principal Investigator: David Avigan, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, MD    617-632-4218    jlaubach@partners.org   
Principal Investigator: Jacob Laubach, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, MD    617-632-4218    jlaubach@partners.org   
Principal Investigator: Jacob Laubach, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Noopur Raje, MD    617-726-0711    nraje@partners.org   
Principal Investigator: Noopur Raje, MD         
Massachusetts General Hospital/North Shore Cancer Center Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Andrew Yee, MD    617-726-6801    ayee1@partners.org   
Principal Investigator: Andrew Yee, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Noopur Raje, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01782963     History of Changes
Other Study ID Numbers: 12-498
Study First Received: January 15, 2013
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Newly diagnosed

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents

ClinicalTrials.gov processed this record on October 21, 2014