DREAMM-6 : A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaMultiple Myeloma

Trial Overview Read MoreRead more

This phase II trial is measuring the safety and recommended dose of an immunotherapy drug (GSK2857916) in combination with another cancer drug (Bortezomib or Lenalidomide) and a steroid for the treatment of multiple myeloma that has gotten worse or is not responsive to other treatments.
 

This trial is treating patients with multiple myeloma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma

Commercial Sponsor

GlaxoSmithKline

Summary

This is a 2-Part, non-randomised trial. Part 1 is dose escalation phase and Part 2 is dose expansion phase. In each part of the trial, patients will receive 2 treatments, A and B. In Part 1, patients will receive GSK2857916, at dose of 2.5 mg/kg with either Len/Dex or Bor/Dex (Arm A and B), if well tolerated escalated to 3.4 mg/kg in next cohort of patients to determine the recommended phase two (RP2D) dose. If not tolerated, lower dose, 1.9 mg/kg, will be administered. In Part 2 (Dose Expansion Phase) additional patients will be treated at the RP2D of GSK2857916 with either Len/Dex or Bor/Dex (Arm A and B) to assess the clinical activity of those combinations.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next