Lenalidomide After Allo Transplant

NCT01750762 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 12-086
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved lenalidomide for your type of cancer. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, this study will determine the effect of lenalidomide on the growth of cancer cells. Lenalidomide is approved by the FDA for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. There are some participants with multiple myeloma or lymphoma who have had very long remissions after a bone marrow/stem cell transplantation from another person. This is believed to be the effect of the donor's immune system reaction against the recipient's multiple myeloma cells. It is hoped that due to lenalidomide altering the immune system, it might be able to potentiate that reaction. This study is being done to determine if the use of lenalidomide is safe in transplant participants and if it can facilitate an immune reaction resulting in regression of the myeloma or lymphoma. During this study you will be evaluated for side effects from the treatment with lenalidomide (including graft versus host disease) and for response of the myeloma to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of lenalidomide. If this is found to be safe then the second group will be treated at a higher dose

Conditions

Multiple Myeloma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Tolerability of lenalidomide

  To determine the tolerability (with special attention to acute or chronic GVHD) and maximum tolerated dose (out of either 10 or 15 mg daily) of lenalidomide in patients with multiple myeloma or lymphoma who do not achieve a CR or relapse after an allogeneic SCT.

  2 years

Secondary Outcomes (3)

• Effect of lenalidomide on T-cells

  2 years

• Effect of lenalidomide on disease response

  2 years

• The effects of lenalidomide on time to progression

  2 years

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Dose escalation. Starting dose is 10 mg/day for 3 weeks followed by 1 week off (1 cycle). Subject will receive a total of 3 cycles.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Also known as: revlimid

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed multiple myeloma or lymphoma and evidence of disease at least 100 days after an allogeneic stem cell or bone marrow transplantation
• Lymphoma patients must have measurable disease
• No previous cancer therapy within 4 weeks
• Life expectancy of at least 3 months
• Free of prior malignancies for at least 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
• Must be registered into RevAssist program and willing and able to comply with RevAssist requirements
• Willing to commit to abstinence or use one highly effective method of birth control and another effective method of birth control at the same time

You may not qualify if:

• Pregnant or breastfeeding
• Any other serious medical condition
• Any condition that places the subject at unacceptable risk if he/she were to participate in the study
• Use of experimental drug or therapy within 28 days of baseline
• Known significant hypersensitivity to thalidomide or lenalidomide
• Development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
• Chemotherapy or radiotherapy within 4 weeks
• Known seropositive for acute HIV, hepatitis B or C
• Significant concurrent infections
• Non-hematological acute GvHD and/or hematological toxicity of Grade 3 or higher
• Moderate or severe chronic GVHD

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Interventions

Lenalidomide

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; Lymphatic 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

Study Officials

• Katarina Luptakova, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 12, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)