Neoplasms

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Multiple Myeloma

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Dexamethasone

Prednisone

Lenalidomide

Dexamethasone acetate

BB 1101

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Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

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Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.

* Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;
* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue

* Starting Dose: 100 mg PO days 1-5 every 28 days;
* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue

* Starting Dose: 40 mg daily on days 1 - 4 every 28 days;
* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue

Rachid Baz, M.D.

The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug, lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma. This means that participants will be given the study drug, lenalidomide but depending on how they respond to this drug they may also be given dexamethasone and/or prednisone to help with their treatment.

Summary: Patients will be started on the study drug, lenalidomide on Day 1, Cycle 1. Lenalidomide is a capsule that is to be taken orally (by mouth). If the patient's disease progresses after 2 cycles of therapy, a low dose of dexamethasone will be added. If the patient's disease is stable after 2 cycles of therapy, the use of an alternate corticosteroid (prednisone) will be added to the lenalidomide therapy they are receiving. Dexamethasone and prednisone are in tablet form and will be taken orally (by mouth). However, if the patient has a minimal response after an additional 2 cycles of lenalidomide therapy, the therapy will be continued until their disease progresses. See the intervention descriptions for further details.

Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed, Standard Risk Multiple Myeloma

Progression free survival (PFS) of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach (i.e. time from start of lenalidomide to failure of lenalidomide and low dose dexamethasone)

Response rate in older adults with mildly symptomatic multiple myeloma to single agent lenalidomide, lenalidomide prednisone and lenalidomide low dose dexamethasone in patients with suboptimal responses to lenalidomide monotherapy. The study used the uniform response assessment of the International Myeloma Working Group with the addition of MR (minimal response) (Durie et al, 2006; Kumar et al, 2016). MR was defined as a 25-49% decrease in serum M spike, and a 50-89% improvement in urine M spike. For patients without a measurable serum or urine M spike, a 25-49% decrease in the difference between the involved and uninvolved free light chains was required. The response in this trial is defined as complete remission (CR), stringent complete remission (SRC), very good partial remission (VGPR) and partial remission (PR) and minimal response (MR).

Number of participants with serious adverse events

The progression free survival of patients treated with single agent lenalidomide

The 1 year overall survival of older adults with mildly symptomatic multiple myeloma treated on this response adapted approach

Celgene

H. Lee Moffitt Cancer Center and Research Institute

All participants treated with Lenalidomide, prednisone and lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.

All Participants

Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions.

Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;

* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;
* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;
* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;
* Dose Level -4: Discontinue

Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days;

* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;
* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;
* Dose level -3: Discontinue

Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days;

* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;
* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;
* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;
* Dose level -3: Discontinue

Spots Global Cancer Trial Database for Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

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