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Report for Clinical Trial NCT03110822

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients

This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease.

NCT03110822 Multiple Myeloma
MeSH: Multiple Myeloma Neoplasms, Plasma Cell
HPO: Multiple myeloma

3 Interventions

Name: Ruxolitinib Oral Tablet [Jakafi]

Description: Ruxolitinib will be administered on days 1-28 of the treatment cycle.

Type: Drug

Rux Len and Steroid Rux and Steroid until progression, then add Len

Name: Lenalidomide

Description: Lenalidomide will be administered on Days 1-21 of the treatment cycle.

Type: Drug

Rux Len and Steroid Rux and Steroid until progression, then add Len

Name: Methylprednisolone

Description: Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.

Type: Drug

Rux Len and Steroid Rux and Steroid until progression, then add Len


Primary Outcomes

Description: MTD will be determined by measuring incidence of the dose-limiting toxicities (DLTs) per dose level, of ruxolitinib in combination with steroids and lenalidomide for MM patients currently with progressive disease.

Measure: Determination of maximum tolerated dose (MTD) of ruxolitinib in combination with steroids and lenalidomide [Tolerability].

Time: 30 months

Description: Safety will be measured by counting the occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 criteria

Measure: Incidence of Treatment-Emergent Adverse Events [Safety]

Time: 54 months

Secondary Outcomes

Description: Overall response rate (ORR) is defined as CR + VGPR + PR

Measure: Overall response rate (ORR) as a measure of efficacy

Time: 54 months

Description: Clinical benefit rate is defined as ORR + MR

Measure: Clinical benefit rate (CBR) as a measure of efficacy

Time: 54 months

Description: Progression-free survival will be measured in months as the time from initiation of therapy to progressive disease or death from any cause, whichever occurs first

Measure: Progression Free Survival (PFS)

Time: 54 months

Description: Time to response, defined as the time from the initiation of therapy to the first evidence of confirmed clinical benefit defined as > minimal response (MR, including patients who achieved a complete response (CR), very good partial response (VGPR), partial response (PR), or MR

Measure: Assessment of the time to response as a measure of efficacy

Time: 54 months

Description: Duration of response, defined as the time (in months) from the first response to progressive disease

Measure: Assessment of the duration of response as a measure of efficacy

Time: 54 months

Description: Overall survival, defined as the time (in months) from initiation of therapy to death from any cause or last follow-up visit

Measure: Assessment of the overall survival (OR) as a measure of efficacy

Time: 54 months

Description: Response to initial therapy (ruxolitinib and methylprednisolone alone) will be compared to the response to therapy with addition of lenalidomide (ruxolitinib, lenalidomide, methylprednisolone)

Measure: Assessment of response in additional cohort

Time: 54 months

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 V617F

The activating JAK2 V617F mutation results in uncontrolled cytokine and growth factor signaling, and is believed to play a key role in the pathophysiology of myeloproliferative neoplasms. --- V617F ---



HPO Nodes


HPO:
Multiple myeloma
Genes 3
LIG4 CCND1 GBA