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

January 15, 2013
August 12, 2013
March 2013
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01782963 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
A Phase II Study of Modified Lenalidomide, Bortezomib and Dexamethasone for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma

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.

If you are willing to participate in this study you will be asked to undergo some screening procedures and tests to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care. They may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, physical exam, performance status, vital signs, neurological exam, bone imaging studies, chest x-ray, bone marrow aspirate, ECG, blood tests and urine tests. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in the research study.

For cycles 1-9 (each cycle lasts 35 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib- once a day on Days 1, 8, 15 and 22. If you are one of the first ten patients enrolled you will get Bortezomib as an intravenous injection for the first cycle. You will get Bortezomib as an injection under the skin for all other cycles. If you are not one of the first 10 patients enrolled you will get Bortezomib as an injection under the skin for all cycles. Dexamethasone-if you are 75 years old or younger you will get Dexamethasone on Days 1, 2, 8, 9, 15, 16, 22 and 23. If you are more than 75 years old you will get Dexamethasone on Days 1, 8, 15 and 22. You will take Dexamethasone by mouth at the same time each day.

For cycles 10-15 (each cycle lasts 28 days) you will receive the following: Lenalidomide-once a day on Days 1-21. You will take Lenalidomide by mouth at the same time each day. Bortezomib-Once a day on Days 1 and 15. You will get Bortezomib as an injection under the skin. You will be given a drug diary to record taking your doses of the drugs. The study staff will tell you how to complete the diary.

During the study you will have to come to the clinic for visits. The tests and procedures that will be done at each visit are listed below:

Day 1 of all cycles: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum (cycle 1 only), urine test.

Day 8 of cycles 1-9: questions about health, medications etc., vital signs, blood tests.

Day 15 of all cycles: questions about health, medications, etc., vital signs, blood tests, pregnancy test.

Day 22 of cycles 1-9: questions about health, medications, etc., vital signs, blood tests.

After the final dose of the study drug you will have an End of Treatment visit. The following tests and procedures will be done at this visit: questions about health, medications etc., physical exam, performance status, vital signs, neurological exam, questionnaires, bone imaging studies, bone marrow aspirate, blood tests, pregnancy test, education and counseling, collection of bone marrow, plasma and serum, urine test.

After your End of Treatment visit, we would like to follow your status every 2 months until your disease gets worse. The following tests and procedures will be done at these follow-up visits: questions about health, medications, symptoms etc., blood tests and urine test.

If you are one of the first twenty patients enrolled in the study you will also be asked to provide additional blood samples to study what the body does to the study drug. We will take one sample at five time points during cycle 1 and 2. Collection of these samples may require you to come back into the clinic on additional days when you are not receiving study drugs.

You will be in this research study for about 15 months. You can be in this study for a maximum of 15 cycles. If your disease gets worse before the 15th cycle you will be taken off the study.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Lenalidomide
    Other Name: Revlimid
  • Drug: Bortezomib
    Other Name: Velcade
  • Drug: Dexamethasone
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

Interventions:
  • Drug: Lenalidomide
  • Drug: Bortezomib
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Noopur Raje, MD 6177260711 nraje@partners.org
United States
 
NCT01782963
12-498
Yes
Noopur Raje, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP