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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01782963
Recruitment Status : Active, not recruiting
First Posted : February 4, 2013
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Noopur Raje, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Lenalidomide Drug: Bortezomib Drug: Dexamethasone Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 years ]
    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 :
  1. Evaluation of Safety Profile [ Time Frame: 2 years ]
    To evaluate the safety profile of modified RVD in previously untreated MM patients who are transplant-ineligible

  2. Progression Free Survival [ Time Frame: 2 years ]
    To evaluate the progression-free survival of modified RVD

  3. Overall Survival [ Time Frame: 2 years ]
    To evaluate the overall survival of modified RVD

  4. Time to Response and Response Duration [ Time Frame: 2 years ]
    Evaluate the time to response and response duration of modified RVD

  5. Response Rate with Respect to Cytogenetic Characteristics [ Time Frame: 2 years ]
    To evaluate the response rate with respect to cytogenetic characteristics of the bone marrow plasma cells.

  6. Evaluate Pharmacokinetic Profile [ Time Frame: 2 years ]
    To evaluate the pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.

  7. Evaluate Pharmacogenomic Markers [ Time Frame: 2 years ]
    To evaluate pharmacogenomic markers among patients with treatment related neuropathy.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01782963

United States, Maryland
John Hopkins University
Baltimore, Maryland, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Noopur Raje, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01782963     History of Changes
Other Study ID Numbers: 12-498
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Noopur Raje, Massachusetts General Hospital:
Newly diagnosed

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal