M15-654 : A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or 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 evaluating the combination of two anti-cancer therapies (Venetoclax and Daratumumab) and a steroid (Dexamethasone), with or without (Bortezomib) chemotherapy in patients with Multiple Myeloma.
 

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 treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

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

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

Commercial Sponsor

AbbVie

Summary

This is a non-randomised, dose escalation and expansion trial. In this trial, Venetoclax will be administered orally at varying doses, as determined by the dose-escalation phase. Venetoclax will be administered in combination with Daratumumab (16 mg/kg IV), which will be given in accordance with prescribing information. Bortezomib will be administered via 1.3mg/m2 subcutaneous injection and dexamethasone will be administered orally or by IV, as described in the protocol.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

St Vincent's Hospital, Haematology Oncology Research
Fitzroy
Ms Lisa Demosthenous
lisa.demosthenous@svha.org.au
03 9231 3182

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.

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