Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

Janssen (J&J Innovative Medicine)

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Part 1 (Dose Escalation): Daratumumab

Drug: Lenalidomide

Drug: Part 2 (Dose Expansion): Daratumumab

Drug: Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01615029

2011-005709-62 (EudraCT Number)

GEN503 (Other Identifier)

CR101391

DARA-GEN503 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

Full description

The study is conducted in two parts. The dose escalation portion of the trial (Part 1) participants are enrolled into cohorts at increasing dose levels of daratumumab in combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex)
(Part 2) Have received at least 1 prior line of therapy for multiple myeloma
Be older than or be 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed

Exclusion criteria

Have previously received an allogenic stem cell transplant
Have received autologous stem cell transplant within 12 weeks before the first infusion
Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion
Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either, participants whose disease progresses within 60 days of lenalidomide, or participants whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an minimal response (MR) or development of progressive disease (PD) while on lenalidomide